us fda approved drug list

7/31/2019 us fda approved drug list

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Dermatology/Plastic Surgery

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Endocrinology

Bio-T-Gel (testosterone gel); Teva Pharmaceuticals; For the treatment of hypogonadism, Approved February 2012

Elelyso (taliglucerase alfa); Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012

Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February

2012

Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s

syndrome, Approved February 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency

due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic

pancreatitis or pancreatectomy, Approved March 2012

Gastroenterology


Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency

due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic

pancreatitis or pancreatectomy, Approved March 2012

Hematology


Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012

Immunology/Infectious Diseases

http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1183
















































Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial

allergic rhinitis, Approved March 2012

Musculoskeletal


Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012

Nephrology/Urology

Afinitor (everolimus); Novartis Pharmaceuticals Corporation; For the treatment of renal angiomyolipoma associated with

tuberous sclerosis complex, Approved April 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012


Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with

impaired renal function, Approved January 2012

Neurology


Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved

January of 2012

Obstetrics/Gynecology

Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer HealthCare; For the treatment of heavy menstrual

bleeding, Approved March 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Oncology



















































Afinitor (everolimus); Novartis Pharmaceuticals Corporation; For the treatment of renal angiomyolipoma associated with

tuberous sclerosis complex, Approved April 2012

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved

January of 2012

Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012

Ophthalmology

Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February

2012

Otolaryngology

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms

of seasonal allergic rhinitis, Approved May 2012



Pediatrics/Neonatology



Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants,

Approved March 2012

Pharmacology/Toxicology

Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with

impaired renal function, Approved January 2012

Pulmonary/Respiratory Diseases













































Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms

of seasonal allergic rhinitis, Approved May 2012

Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR

gene, Approved January of 2012



Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants,

Approved March 2012

Rheumatology


Cardiology/Vascular Diseases

Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome,

Approved July 2011

Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011

Edarbyclor (azilsartan medoxomil and chlorthalidone); Takeda Pharmaceutical; For the treatment of hypertension,

Approved December of 2011

Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting

from atrial fibrillation, Approved November 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery,

Approved July 2011


Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011



















































Endocrinology

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved October 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Gastroenterology


Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved

May 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention

of gastric ulcers, Approved April 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Rectiv (nitroglycerin) ointment 0.4%; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011


Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Hematology

Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell

lymphoma, Approved August 2011

Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia,

Approved November of 2011

Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October

2011

Jakafi (ruxolitinib); Incyte; For the treatment of myelofibrosis, Approved November 2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery,

Approved July 2011























































Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic

obstructive pulmonary disease, Approved July 2011

Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March

2011

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive

adults, Approved August of 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved

February 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved

May 2011

Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011


Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June

2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Musculoskeletal

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011



Nephrology/Urology Anturol (oxybutynin) Gel; Antares Pharma; For the treatment of overactive bladder, Approved December 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June

2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011



















































Neurology

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant

patients, Approved January 2011

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved

November 2011


Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved

November 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June

2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved

October 2011

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011


Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved

February 2011

Oncology

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant

patients, Approved January 2011

Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell

lymphoma, Approved August 2011


Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia,

Approved November of 2011
















































Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June

2011


Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011

Ophthalmology

Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-related macular degeneration,

Approved November 2011

Otolaryngology

Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011




February 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved

October 2011


Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Psychiatry/Psychology

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved

November 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011




















































Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic

obstructive pulmonary disease, Approved July 2011


February 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Rheumatology




Trauma/Emergency Medicine

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved

November 2011


Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of

uncontrolled hypertension, Approved December 2010

Pradaxa (dabigatran etexilate mesylate); Boehringer Ingeleheim; For the risk reduction of

stroke and embolism due to atrial fibrillation, Approved October 2010

Tekamlo (aliskiren + amlodipine); Novartis; For the treatment of hypertension, Approved

August 2010

Tribenzor (olmesartan medoxomil + amlodipine + hydrochlorothiazide); Daiichi Sankyo;

For the treatment of hypertension, Approved July 2010

Dermatology/Plastic Surgery Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and

bacterial pneumonia, November 2010

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris,

Approved July 2010







































Zyclara (imiquimod); Graceway; For the treatment of actinic keratoses of the face and scalp,

Approved March 2010

Endocrinology

Fortesta (testosterone gel); Endo Pharmaceuticals; For the treatment of hypogonadism,

Approved December 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis

at high risk for fracture, Approved June 2010

Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved

January 2010

Gastroenterology Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October

2010

Pancreaze (pancrelipase); Johnson & Johnson; For the treatment of exocrine pancreatic

insufficiency, Approved April of 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at

risk for NSAID-associated ulcers, Approved April 2010

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of

post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July

2010

Hematology

Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease,

Approved March 2010

Immunology/Infectious DiseasesCayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic

fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal

fat in HIV-infected patients with lipodystrophy, Approved November 2010




































Menveo (meningitis vaccine); Novartis; For the active immunization to prevent invasive

meningococcal disease, Approved February 2010

Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April

2010

Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine); Wyeth; For the active

immunization for the prevention of invasive disease caused by Streptococcus pneumoniae,

Approved February 2010

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and


Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney

transplant, Approved May 2010

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial

conjunctivitis, Approved May 2010

Musculoskeletal

Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved

January 2010

Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple

sclerosis, Approved January 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved

March 2010

Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved

September 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia),

Approved September 2010














































Xeomin (incobotulinumtoxinA); Merz Pharmaceutical; For the treatment of cervical dystonia

and blepharospasm, Approved July 2010

Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with

bone metastases from solid tumors, Approved November 2010

Xiaflex (collagenase clostridium histolyticum); Auxilium Pharmaceuticals; For the treatment

of Dupuytren’s contracture, Approved February 2010

Nephrology/Urology

Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved

March 2010

Jalyn (dutasteride + tamsulosin); GlaxoSmithKline; For the treatment of benign prostatic

hyperplasia, Approved June 2010

Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June

2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer,

Approved May 2010

Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010

Zortress (everolimus); Novartis; For the prevention of organ rejection following kidneytransplant, Approved May 2010

Neurology

Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple

sclerosis, Approved January 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved

March 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved

October 2010

Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic

pain, Approved July 2010










































Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved

March 2010

Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics

with neurologic conditions, Approved July 2010

Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of

moderate to severe pain, Approved March 2010

Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit

hyperactivity disorder, Approved October 2010

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate); Avanir

Pharmaceuticals; For the treatment of pseudobulbar affect, Approved October 2010

Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010

Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain,

Approved May 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the

prevention of relapse to opioid dependence, Approved October 2010

Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease,

Approved March 2010

Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010


ella (ulipristal acetate); HRA Pharma; For the emergency prevention of contraception,

Approved August 2010

Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved

November 2010

Natazia (estradiol valerate + dienogest); Bayer; For the prevention of contraception,

Approved May 2010















































Oncology

Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved

November 2010

Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October

2010

Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June

2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer,

Approved May 2010

Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with

bone metastases from solid tumors, Approved November 2010



2010

Ophthalmology

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial

conjunctivitis, Approved May 2010

Otolaryngology

Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April

2010


Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics

with neurologic conditions, Approved July 2010

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of

asthma, Approved June 2010

Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit

hyperactivity disorder, Approved October 2010




































Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris,

Approved July 2010


Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal

fat in HIV-infected patients with lipodystrophy, Approved November 2010



2010


Latuda (lurasidone); Sunovion; For the treatment of schizophrenia, Approved October 2010

Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive

disorder, Approved February 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the

prevention of relapse to opioid dependence, Approved October 2010


Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic

fibrosis patients with Pseudomonas aeruginosa, Approved February 2010

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of

asthma, Approved June 2010

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and


Rheumatology

Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved

January 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia),







































Trauma/Emergency Medicine



2010


Cleviprex (clevidipine); The Medicines Company; For the treatment of hypertension when oral therapy is not feasible or not

desirable, Approved August 2008

Trilipix (fenofibric acid); Abbott Laboratories; For the treatment of dyslipidemia, hypertriglyceridemia and hyperlipidemia,


Endocrinology

Accretropin (somatropin rDNA Original); Cangene Corp; For the treatment of growth failure in pediatrics, Approved

January 2008

Welchol (colesevelam hydrochloride); Daiichi Sankyo; For the improvement of glycemic control in adults with type 2

diabetes mellitus, Approved January 2008

Gastroenterology Cimzia (certolizumab pegol); UCB; For the treatment of Crohn’s disease, Approved April 2008

Entereg (alvimopan); GlaxoSmithKline; For the treatment of postoperative ileus, Approved May 2008

Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and

non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008

Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved

September 2008

Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe Crohn’s disease, Approved

January 2008

Hematology




































Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and multiple myeloma, Approved

December 2008

Nplate (romiplostim); Amgen; For the treatment of thrombocytopenia in patients with chronic immune (idiopathic)

thrombocytopenic purpura, Approved August 2008

Promacta (eltrombopag); GlaxoSmithKline; For the treatment of thrombocytopenia, Approved November 2008


Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals; For the treatment of seasonal and perennial

allergic rhinitis, Approved October 2008

Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with

Hereditary Angioedema, Approved October 2008

Intelence (etravirine); Tibotec; For the treatment of HIV-1, Approved January 2008

Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to

Streptococcus pyogenes in adults and pediatrics, Approved January 2008



Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe Crohn’s disease, Approved

January 2008

Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008

Musculoskeletal

Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008

Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August

2008

Nephrology/Urology

Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer, Approved December of

2008

Toviaz (fesoterodine fumarate); Pfizer; For the treatment of overactive bladder, Approved October 2008
















































Neurology

Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in

pediatrics and adults, Approved November 2008

Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery,

Approved June 2008

Lusedra (fospropofol disodium); Elan Pharmaceuticals; A sedative-hypnotic agent indicated for monitored anesthesia

care sedation, Approved December of 2008

Nucynta (tapentadol); Ortho-McNeil Janssen; moderate to severe acute pain, Approved November 2008

Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic disorder, seizures and

migraine headaches, Approved July 2008

Vimpat (lacosamide); Schwarz Pharma; For the treatment of partial-onset seizures in adults with epilepsy, Approved

October 2008

Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August

2008

Oncology

Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer, Approved December of

2008

Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma

and to reduce the toxicity of methotrexate, Approved March of 2008

Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and multiple myeloma, Approved

December 2008


September 2008

Treanda (bendamustine hydrochloride); Cephalon; For the treatment of Chronic lymphocytic leukemia and B-cell non-

Hodgkin’s lymphoma, Approved October 2008

Ophthalmology

Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures, Approved October 2008












































Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery,

Approved June 2008

Otolaryngology





Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008


Accretropin (somatropin rDNA Original); Cangene Corp; For the treatment of growth failure in pediatrics, Approved

January 2008

Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and

adolescents, Approved January 2008

Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008

Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in

pediatrics and adults, Approved November 2008

Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with

Hereditary Angioedema, Approved October 2008




















































Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures, Approved October 2008

Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma

and to reduce the toxicity of methotrexate, Approved March of 2008


September 2008


Aplenzin (bupropion hydrobromide); Biovail Laboratories; For the treatment of major depressive disorder, Approved April

2008

Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic disorder, seizures and

migraine headaches, Approved July 2008


Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and

adolescents, Approved January 2008


Rheumatology



Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo; For the treatment of

hypertension, Approved September 2007

Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and

hypertriglyceridemia, Approved August 2007

Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved

June 2007

Soliris (eculizumab); Alexion Pharm; For the treatment of paroxysmal nocturnal

hemoglobinuria, Approved March 2007

Tekturna (aliskiren); Novartis; For the treatment of hypertension, Approved March 2007











































Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus

aureus or Streptococcus pyogenes, Approved April 2007

Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007

Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial

allergic rhinitis and urticaria, Approved May 2007

Endocrinology

Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due

to menopause, Approved July 2007

Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and

hypertriglyceridemia, Approved August 2007

Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly,


Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central

precocious puberty, Approved May 2007

Hematology

Kuvan (sapropterin dihydrochloride); BioMarin Pharmaceuticals; For the treatment of

hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria,


Mircera (methoxy polyethylene glycol-epoetin beta); Roche; For the treatment of anemia

associated with chronic renal failure, Approved November 2007

Soliris (eculizumab); Alexion Pharm; For the treatment of paroxysmal nocturnal

hemoglobinuria, Approved March 2007







































AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved

April 2007

Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and

urinary tract infections, Approved October 2007

Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007

Isentress (raltegravir); Merck; For the treatment of HIV-1, Approved October 2007

Selzentry (maraviroc); Pfizer; For the treatment of CCR5-tropic HIV-1, Approved August 2007

Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial

allergic rhinitis, Approved April 2007

Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennialallergic rhinitis and urticaria, Approved May 2007

Musculoskeletal

Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of

muscle spasm associated with acute, painful musculoskeletal conditions, Approved February

2007

Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and

reduction of breast cancer risk in postmenopausal women, Approved September 2007

Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis,


Reclast (zoledronic acid); Novartis; For the treatment of Paget's disease, Approved April 2007

Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly,


Nephrology/Urology Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and

urinary tract infections, Approved October 2007

Mircera (methoxy polyethylene glycol-epoetin beta); Roche; For the treatment of anemia

associated with chronic renal failure, Approved November 2007













































Renvela (sevelamer carbonate); Genzyme; For the control of serum phosphorus in patients

with chronic kidney disease on dialysis, Approved October 2007

Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007

Neurology Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of

muscle spasm associated with acute, painful musculoskeletal conditions, Approved February

2007

Exelon (rivastigmine tartrate); Novartis; For the treatment of Alzheimer's and Parkinson's

disease-related dementia, Approved July 2007

Neupro (rotigotine); Schwarz Pharma; For the treatment of Parkinson's disease, Approved

May 2007

Nuvigil (armodafinil); Cephalon; For the treatment of excessive sleepiness, Approved June

2007

Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-

Deficit/Hyperactivity Disorder, Approved February 2007


Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due

to menopause, Approved July 2007

Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and


Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis,


Oncology Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and


Hycamtin (topotecan hydrochloride); GlaxoSmithKline; For the treatment of small cell lung

cancer, Approved October 2007







































Ixempra (ixabepilone); Bristol-Myers Squibb; For the treatment of breast cancer, Approved

October 2007

Tasigna (nilotinib hydrochloride monohydrate); Novartis; For the treatment of chronic

myelogenous leukemia, Approved October 2007

Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007

Tykerb (lapatinib); GlaxoSmithKline; For the treatment of breast cancer, Approved March 2007

Ophthalmology

AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved

April 2007

Otolaryngology Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial







Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central

precocious puberty, Approved May 2007

Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial


Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-










































Zingo (lidocaine hydrochloride monohydrate); Anesiva; For local analgesia prior to

venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age, Approved

August 2007

Psychiatry/Psychology Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-



Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved

June 2007

Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennialallergic rhinitis and urticaria, Approved May 2007


Ranexa (ranolazine); CV Therapeutics; For the treatment of chronic angina in patients failing first-line therapy, Approved

January 2006


Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006

Verdeso (desonide); Connetics Corporation; For the treatment of atopic dermatitis, Approved September 2006

Endocrinology

Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with menopause, Approved

December 2006

Januvia(sitagliptin phosphate); Merck; For the treatment of type II diabetes, Approved October 2006

Gastroenterology

Amitiza (lubiprostone); Sucampo/Takeda; For the treatment of chronic idiopathic constipation, Approved January 2006

Hematology

Dacogen (decitabine); MGI Pharma; For the treatment of both treatment-naïve and -experienced Myelodysplastic

Syndromes, Approved May 2006





































Eraxis (anidulafungin); Pfizer; For the treatment of Candida fungal infections, Approved February 2006

Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); Merck; For the prevention of

cervical cancer associated with human papillomavirus, Approved June 2006

Noxafil (posaconazole); Schering-Plough; For the treatment of fungal infections, Approved in September 2006

Prezista (darunavir); Tibotec; For the treatment of treatment-resistant HIV infections, Approved June 2006

Rotateq (rotavirus vaccine, live oral pentavalent); Merck; For the prevention of gastroenteritis associated with rotavirus

infections in infants, Approved February 2006

Tyzeka (telbivudine); Idenix Pharma; For the treatment of hepatitis B virus, Approved October 2006

Veregen (kunecatechins); Medigene; For the treatment of external genital and perianal warts, Approved October 2006

Neurology

Invega (paliperidone); Janssen Pharmaceutica; For the treatment of schizophrenia, Approved December 2006

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of alcohol dependence,

Approved April 2006


Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with menopause, Approved

December 2006

Oncology

Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); Merck; For the prevention of

cervical cancer associated with human papillomavirus, Approved June 2006

Sprycel (dasatinib); Bristol-Myers Squibb; For the treatment of imatinib-resistant chronic myeloid leukemia, Approved June

2006

Sutent (sunitinib); Pfizer; For the treatment of kidney cancer and gastrointestinal stromal tumors, Approved January 2006

Vectibix (panitumumab); Amgen; For the treatment of colorectal cancer, Approved September 2006

Ophthalmology













































Lucentis (ranibizumab); Genentech; For the treatment of neovascular (wet) age related macular degeneration, Approved

June 2006


Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006

Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II (Hunter Syndrome),

Approved July 2006

Myozyme (alglucosidase alfa); Genzyme; For the treatment of Pompe disease (glycogen storage disease type II),

Approved April 2006


Chantix (varenicline); Pfizer; For the treatment of nicotine addiction, Approved May 2006

Invega (paliperidone); Janssen Pharmaceutica; For the treatment of schizophrenia, Approved December 2006

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of alcohol dependence,

Approved April 2006


Brovana (arformoterol tartrate); Sepracor; For the treatment of Chronic Obstructive Pulmonary Disease, Approved in

October 2006

Rheumatology

Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II (Hunter Syndrome),

Approved July 2006


BiDil (isosorbide dinitrate/hydralazine hydrochloride); NitroMed; For the treatment of heart

failure in black patients, Approved June, 2005


Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure and

intra-abdominal infections and bacterial pneumonia, Approved 2005

Endocrinology




































ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride); Takeda; For the

treatment of type 2 diabetes, Approved August of 2005

Byetta (exenatide); Amylin/Eli Lilly; For the adjunctive treatment of Type 2 diabetes mellitus,

Approved April, 2005

Increlex (mecasermin); Tercica; For the treatment of growth failure due to Primary IGFD,


Symlin (pramlintide); Amylin Pharmaceuticals; For the treatment of type I and type II diabetes,

Approved March 2005

Gastroenterology



Hematology

Revlimid (lenalidomide); Celgene; For the treatment of low- and intermediate-1-risk

myelodysplastic syndromes, Approved December 2005


Aptivus (tipranavir); Boehringer Ingelheim; For the adjunctive treatment of HIV-1 infections,

Approved June, 2005

Baraclude (entecavir); Bristol-Myers Squibb; For the treatment of chronic hepatitis B infections

with evidence of active viral replication, Approved March, 2005



Musculoskeletal

Boniva (ibandronate); Roche / GlaxoSmithKline; For the treatment and prevention of

osteoporosis, Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH,

2005

Naglazyme (galsulfase); BioMarin Pharmaceuticals; For the treatment of

mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), Approved May 2005




































Nephrology/Urology

Vaprisol (conivaptan); Astellas; For the treatment of euvolemic hyponatremia, Approved

December 2005

Neurology

Rozerem (ramelteon); Takeda; For the treatment of sleep-onset insomnia, Approved July,

2005

Tysabri (natalizumab); Elan Pharmaceuticals / Biogen Idec; For the treatment of relapsing

forms of multiple sclerosis, Approved November 2004 -- Updated: Suspended February 2005--

Updated: sBLA

Oncology Arranon (nelarabine); GlaxoSmithKline; For the treatment of T-cell acute lymphoblastic

leukemia and T-cell lymphoblastic lymphoma, Approved October 2005

Nexavar (sorafenib); Bayer/Onyx; For the Treatment of Renal Cell Carcinoma, Approved

December 2005


Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure andintra-abdominal infections and bacterial pneumonia, Approved 2005

Rheumatology

Orencia (abatacept); Bristol-Myers Squibb; For the Treatment of Rheumatoid Arthritis,



Caduet (amlodipine/atorvastatin ); Pfizer; For the treatment of hypertension, chronic stableangina and vasospastic angina, Approved January 2004

Gastroenterology

Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or

rectum, Approved February 2004






























Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing,

metastatic colorectal cancer, Approved February 2004

Hematology

Vidaza (azacitidine); Pharmion Corporation; For the treatment of several myelodysplastic

syndrome subtypes including refractory and chronic myelomonocytic leukemias, Approved May

2004


Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis,

bacterial sinusitis and Community-acquired pneumonia., Approved April 2004

Tindamax, tinidazole; Presutti Laboratories; For the treatment of microbial infections, includingtrichomoniasis, giardiasis, and amebiasis, Approved May, 2004

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of Travelers' diarrhea caused by

noninvasive strains of Escherichia coli, Approved May 2004

Musculoskeletal

Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 --

UPDATED: WITHDRAWN OCTOBER 2004

Nephrology/Urology

Fosrenol, lanthanum carbonate; Shire Pharmaceuticals; For the treatment of

hyperphosphatemia related to kidney dysfunction, Approved October, 2004

Sanctura (trospium chloride); Indevus Pharmaceuticals; For the treatment of overactive

bladder with symptoms of urge urinary incontinence, Approved May, 2004

Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and

hypercalcemia in parathyroid carcinoma patients, Approved March 2004

Vesicare (solifenacin succinate); Yamanouchi, GlaxoSmithKline; For the treatment of

overactive bladder with symptoms of urge urinary incontinence, Approved November, 2004

Neurology

































Apokyn (apomorphine hydrochloride); Mylan Bertek Pharmaceuticals; For the treatment of

acute, intermittent hypomobility episodes associated with advanced Parkinson’s disease,

Approved April, 2004

Lunesta (eszopiclone); Sepracor; For the treatment of insomnia and sleep maintenance,Approved December 2004

Lyrica (pregabalin); Pfizer; For the treatment of pain associated with diabetic peripheral

neuropathy and postherpetic neuralgia, Approved December 2004


EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals; For the treatment of vasomotor

symptoms and vulvar and vaginal atrophy associated with menopause, Approved April 2004

Oncology

Alimta (pemetrexed for injection); Eli Lilly; For the treatment of malignant pleural

mesothelioma, Approved February 2004

Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or

rectum, Approved February 2004

Clolar (clofarabine); Genzyme; For the treatment of acute lymphoblastic leukemia in pediatric

patients, Approved December, 2004

Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing,

metastatic colorectal cancer, Approved February 2004

Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and

hypercalcemia in parathyroid carcinoma patients, Approved March 2004

Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals; For the treatment of advanced

refractory metastatic non-small cell lung cancer, Approved November, 2004

Ophthalmology

Macugen (pegaptanib); Pfizer / Eyetech Pharmaceuticals; For the treatment of wet age-related

macular degeneration., Approved December 2004





































Campral (acamprosate calcium); Forest Laboratories; For the treatment of alcohol

dependence and the maintenance of alcohol abstinence, Approved August, 2004


Cymbalta (duloxetine); Eli Lilly; For the treatment of major depressive disorder, Approved

August 2004


Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis,

bacterial sinusitis and Community-acquired pneumonia., Approved April 2004

Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim; For the treatment of

bronchospasm associated with chronic obstructive pulmonary disease, Approved February2004

Rheumatology

Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 --

UPDATED: WITHDRAWN OCTOBER 2004

2003


Crestor (rosuvastatin calcium); AstraZeneca; For the treatment of primary hypercholesterolemia (heterozygous familial

and nonfamilial) and mixed dyslipidemia, Approved August 2003

Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men,



Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003

Finacea (azelaic acid) Gel, 15%; Berlex Laboratories; Gel formulation for the treatment of rosacea., January 2003

Endocrinology

Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65,

Approved May 2003

































Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients, Approved April 2003

Somavert (pegvisomant); Pharmacia; Injectable formulation for the treatment of acromegaly, Approved March 2003

Gastroenterology

Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting associated with

emetogenic cancer chemotherapy, Approved August 2003

Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with chemotherapy, Approved March

2003

Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of overactive bladder with

symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003

Hematology Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following

chemotherapy relapse, Approved June 2003



Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other

antiretroviral agents, Approved July 2003

Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-

1) and emphysema, Approved July 2003


Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003

FluMist ( Influenza Virus Vaccine); MedImmune; For the prevention of disease caused by influenza A and B viruses,

Approved June 2003

Fuzeon (enfuvirtide); Trimeris, Roche; For the treatment of HIV-1 infection in combination with other antiretroviral agents,

Approved March 2003

Lexiva (fosamprenavir calcium); GlaxoSmithKline; For the treatment of HIV infection in adults in combination with other

antiretroviral agents., Approved October 2003

Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other

antiretroviral agents, Approved July 2003













































Musculoskeletal


Approved May 2003

Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor

menopause symptoms, Approved July of 2003

Somavert (pegvisomant); Pharmacia; Injectable formulation for the treatment of acromegaly, Approved March 2003

Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple myeloma patients who

have received at least two prior therapies., Approved May 2003

Nephrology/Urology

Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients, Approved April 2003

Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of overactive bladder with

symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003

UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the signs and symptoms of

benign prostatic hyperplasia, Approved June 2003

Neurology

Cialis (tadalafil); Eli Lilly; Oral agent for the treatment for erectile dysfunction, Approved December 2003



Namenda (memantine HCl); Forest Laboratories; For the treatment of moderate to severe dementia of the Alzheimer’s

type., Approved October 2003




Seasonale, Lo Seasonale, Seasonique (ethinylestradiol + levonorgestrel); Duramed; For the prevention of

contraception, Approved September 2003

Oncology







































Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting associated with

emetogenic cancer chemotherapy, Approved August 2003

Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following

chemotherapy relapse, Approved June 2003

Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with chemotherapy, Approved March

2003

Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003

Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals; For treatment of advanced prostate cancer,




UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the signs and symptoms of

benign prostatic hyperplasia, Approved June 2003

Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple myeloma patients who

have received at least two prior therapies., Approved May 2003



Approved May 2003



Approved May 2003

Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003

Xolair (omalizumab); Genentech; For the treatment of asthma, Approved June 2003

Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-

1) and emphysema, Approved July 2003

2002











































Altocor (lovastatin) Extended-Release Tablets; Andrx; Oral tablets for the adjuctive treatment of hypercholesterolemia,

Approved June 2002

Benicar; Daiichi Sankyo; Oral tablet for the treatment of hypertension, Approved April 2002

Imagent (perflexane lipid microspheres); Alliance Pharmaceutical; Ultrasound contrast agent for improved imaging of the

heart, Approved June 2002

Inspra (eplerenone tablets); Pharmacia; Oral tablets for the treatment of high blood pressure., Approved September 2002

Plavix (clopidogrel bisulfate); Sanofi-aventis; For the treatment of acute coronary syndrome, Approved February 2002

Remodulin (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension in patients with NYHA

Class II-IV symptoms, Approved May 2002

Dermatology/Plastic Surgery Botox Cosmetic (botulinum toxin type A); Allergan; For the temporary improvement in the appearance of glabellar lines

(brow furrow), Approved April 2002

Endocrinology

Avandamet (rosiglitazone maleate and metformin HCl); GlaxoSmithKline; For improvement of glycemic control in type 2

diabetes patients, Approved October 2002

Benicar; Daiichi Sankyo; Oral tablet for the treatment of hypertension, Approved April 2002

Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals; Human-derived follicle-stimulating hormone

(hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002

Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk

for a fracture., December 2002

Levo-T (levothyroxine sodium); Mova Pharmaceutical; Indicated for the treatment of hypothyroidism and the suppression

of thyroid stimulating hormone, Approved March 2002

Metaglip (glipizide/metformin HCl); Bristol-Myers Squibb; Oral tablets for the treatment of type 2 diabetes., Approved

October 2002

Novothyrox (levothyroxine sodium); Genpharm; For the treatment of hypothyroidism and suppression of thyroid-

stimulating hormone, Approved May 2002

Synthroid (levothyroxine sodium); Abbott Laboratories; For replacement or supplemental therapy for hypothyroidism and

pituitary thyroid stimulating hormone suppression, Approved July 2002
















































Testim; Auxilium Pharmaceuticals; External cream for the treatment of male hormone deficiency., Approved October 2002

Gastroenterology

Aciphex (rabeprazole sodium); Elan Pharmaceuticals; For the treatment of symptomatic gastroesophageal reflux disease,


Alinia (nitazoxanide); Romark Laboratories; For the treatment Diarrhea caused by Cryptosporidium and Giardia in

children., December 2002

Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis; For the treatment of colon or rectum carcinomas,


Gleevec (imatinib mesylate); Novartis; For the treatment of gastrointestinal stromal tumors (GISTs), Approved February

2002

Hepsera (adefovir dipivoxil); Gilead; For the treatment of chronic hepatitis B in adults with evidence of active viral

replication, Approved September 2002

Orfadin (nitisinone); Orphan Pharmaceuticals; Capsules for the treatment of hereditary tyrosinemia type I, Approved

January 2002

Pegasys (peginterferon alfa-2a); Roche; For the treatment of chronic hepatitis C who have compensated liver disease,

Approved October 2002

Protonix (pantoprazole sodium) Delayed Release Tablets; Wyeth; Oral tablets for the treatment of gastroesophageal and

pathological hypersecretory conditions, Approved April 2002

SecreFlo (secretin); Repligen; To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002

Zelnorm (tegaserod maleate) Tablets; Novartis; For the short-term treatment of irritable bowel syndrome in women whose

primary bowel symptom is constipation, Approved July 2002

Zelnorm (tegaserod maleate) Tablets; Novartis; For the short-term treatment of irritable bowel syndrome in women whose

primary bowel symptom is constipation, Approved July 2002

Hematology

Neulasta; Amgen; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy,

Approved January 2002













































Clarinex; Schering-Plough; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria,


Daptacel; Sanofi Pasteur; Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002

Fluzone Preservative-free; Sanofi Pasteur; Preservative free, pediatric dose, influenza virus vaccine for the immunization

of infants, Approved September 2002

Hepsera (adefovir dipivoxil); Gilead; For the treatment of chronic hepatitis B in adults with evidence of active viral

replication, Approved September 2002

Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6

weeks to 7 years old., Approved December 2002

Pegasys (peginterferon alfa-2a); Roche; For the treatment of chronic hepatitis C who have compensated liver disease,


Restasis (cyclosporine ophthalmic emulsion); Allergan; For the treatment of low tear production., December 2002

Sustiva; Bristol-Myers Squibb; Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002

Vfend (voriconazole); Pfizer; For the treatment of fungal infections, Approved May 2002

Musculoskeletal

Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of

vasomotor menopausal symptoms, Approved April 2002

Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous,

around-the-clock therapy, Approved March 2002



Remicade (infliximab); Centocor; Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002

Testim; Auxilium Pharmaceuticals; External cream for the treatment of male hormone deficiency., Approved October 2002

Vivelle-Dot (estradiol transdermal system); Novartis; For the prevention of post-menopausal osteoporosis, Approved May

2002



















































Nephrology/Urology

Eligard (leuprolide acetate); Atrix Laboratories; For the palliative treatment of advanced prostate cancer, Approved

January 2002

Mesnex; Bristol-Myers Squibb, Baxter Healthcare; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide),

Approved March 2002

Neurology

Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous,

around-the-clock therapy, Approved March 2002

Neurontin (gabapentin); Pfizer; Oral treatment for the management of post-herpetic neuralgia (PHN), Approved May 2002

Rebif (interferon beta-1a); Serono Laboratories; Subcutaneous injection for the treatment of relapsing forms of multiple

sclerosis, Approved March 2002

Relpax (eletriptan hydrobromide); Pfizer; For the acute treatment of migraine headaches, Approved December 2002

Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children,

adolescents and adults., December 2002

Xyrem (sodium oxybate); Orphan Medical; For the treatment of cataplexy, a sudden loss of muscle tone, associated with

narcolepsy, Approved July 2002

Obstetrics/Gynecology Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of

vasomotor menopausal symptoms, Approved April 2002

Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals; Human-derived follicle-stimulating hormone

(hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002



Vivelle-Dot (estradiol transdermal system); Novartis; For the prevention of post-menopausal osteoporosis, Approved May

2002

Zoloft (sertraline HCl); Pfizer; Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved

May 2002

Oncology










































Eligard (leuprolide acetate); Atrix Laboratories; For the palliative treatment of advanced prostate cancer, Approved

January 2002

Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis; For the treatment of colon or rectum carcinomas,


Faslodex (fulvestrant); AstraZeneca; For the treatment of hormone receptor positive metastatic breast cancer, Approved

April 2002

Gleevec (imatinib mesylate); Novartis; For the treatment of gastrointestinal stromal tumors (GISTs), Approved February

2002

Neulasta; Amgen; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy,


SecreFlo (secretin); Repligen; To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002

Zevalin (ibritumomab tiuxetan); Biogen IDEC; For the treatment of non-Hodgkin's lymphoma, Approved February 2002

Zometa (zoledronic acid); Novartis; For the treatment of multiple myeloma and bone metastases from solid tumors,


Ophthalmology

Restasis (cyclosporine ophthalmic emulsion); Allergan; For the treatment of low tear production., December 2002




Daptacel; Sanofi Pasteur; Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002

Fluzone Preservative-free; Sanofi Pasteur; Preservative free, pediatric dose, influenza virus vaccine for the immunization

of infants, Approved September 2002

Orfadin (nitisinone); Orphan Pharmaceuticals; Capsules for the treatment of hereditary tyrosinemia type I, Approved

January 2002

Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6

weeks to 7 years old., Approved December 2002

Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002
















































Ritalin LA (methylphenidate HCl); Novartis; Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder

(ADHD), Approved June 2002




Mesnex; Bristol-Myers Squibb, Baxter Healthcare; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (i fosfamide),

Approved March 2002

Subutex/Suboxone (buprenorphine/naloxone); Reckitt Benckiser; Oral tablets for the treatment of opiate dependence,



Abilify (aripiprazole); Bristol-Myers Squibb, Otsuka America Pharmaceutical; Oral drug for the treatment of schizophrenia,


Geodon (ziprasidone mesylate); Pfizer; To control agitated behavior and psychotic symptoms in schizophrenia patients,

Approved June 2002

Lexapro (escitalopram oxalate); Forest Laboratories; An orally administered selective serotonin reuptake inhibitor useful

for the treatment for major depressive disorder, Approved August 2002

Paxil CR (paroxetine hydrochloride); GlaxoSmithKline; Oral tablet for the treatment of depression and panic disorder,


Ritalin LA (methylphenidate HCl); Novartis; Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder

(ADHD), Approved June 2002



Subutex/Suboxone (buprenorphine/naloxone); Reckitt Benckiser; Oral tablets for the treatment of opiate dependence,


Zoloft (sertraline HCl); Pfizer; Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved

May 2002








































Clarinex; Schering-Plough; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria,


Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002

Remodulin (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension in patients with NYHA

Class II-IV symptoms, Approved May 2002

Xopenex; Sepracor; Inhaled solution for treatment of reversible obstructive airway disease, Approved February 2002

Rheumatology

Enbrel (etanercept); Immunex; For the treatment of psoriatic arthritis, Approved January 2002

Humira (adalimumab); Abbott Laboratories; For the treatment of moderately to severely active rheumatoid arthritis,


Remicade (infliximab); Centocor; Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002

2001


Advicor (extended-release niacin/lovastatin); Kos Pharmaceuticals; For the treatment of cholesterol disorders, Approved

December 2001

Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997

(capsules); July 2001 (tablets)

Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved

August 2001

Teveten (eprosartan mesylate plus hydrochlorothiazide); Unimed Pharmaceuticals; Tablets for the treatment of

hypertension, Approved November 2001

Tricor (fenofibrate); Abbott Laboratories; For the treatment of primary hypercholesterolemia, mixed lipidemia and

hypertriglyceridemia, Approved September 2001

Dental/Maxillofacial Surgery

Arestin (minocycline hydrochloride); OraPharma; For treatment of adult periodontitis, Approved February 2001










































Periostat (doxycycline hyclate); CollaGenex Pharmaceuticals; Oral tablet for adjunctive treatment of adult periodontitis,



Elidel; Novartis; Topical cream for the treatment of atopic dermatitis, Approved December 2001

Estrostep (norethindrone acetate and ethinyl estradiol); Pfizer; For the treatment of moderate acne vulgaris, Approved

July 2001

Finevin; Berlex Laboratories; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris, Approved

May 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm,

Approved March 2001

Endocrinology

Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001

Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997

(capsules); July 2001 (tablets)

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast

cancer, Approved January 2001

Genotropin (somatropin) injection; Pharmacia; For the treatment of growth failure in children who were born small for

gestational age (SGA), Approved July 2001

Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001

Levoxyl; Jones Pharma; Oral therapy for the treatment of hypothyroidism and suppression of thyroid-stimulating hormone

(TSH), Approved May 2001

Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved

August 2001

Novolog Mix 70/30; Novo Nordisk; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2

diabetes, Approved November 2001

Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001
















































Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January

2001

Remicade (infliximab); Centocor; For inhibiting the progression of structural damage in patients with rheumatoid arthritis,


Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate

cancer, Approved June 2001

Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001

Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001

Gastroenterology

Canasa (mesalamine); Axcan; For the treatment of active ulcerative proctitis, Approved January 2001

Entocort EC (budesonide); AstraZeneca; Capsules for the treatment of mild-to-moderate, active Crohn's disease,


Nexium (esomeprazole magnesium); AstraZeneca; For the eradication of Helicobacter pylori, the healing of erosive

esophagitis, and the treatment of symptomatic GERD, Approved February 2001

Protonix (pantoprazole sodium) Intravenous Formulation; Wyeth; For the short-term treatment of gastroesophageal

reflux disease, Approved March 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Hematology

Arixtra; Organon, Sanofi-Synthelabo; Injectable solution for the prevention of deep vein thrombosis, Approved December

2001


Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of

bacterial infections, Approved November 2001

Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001

Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001



















































Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August

2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March

2001

Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus

(HIV) infection, Approved October 2001

Xigris (drotrecogin alfa [activated]); Eli Lilly; For the treatment of severe sepsis, Approved November 2001

Musculoskeletal



Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001

Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January

2001

Nephrology/Urology

dutasteride; GlaxoSmithKline; For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001


PhosLo; Braintree Laboratories; Oral capsules and gelcaps for the control of hyperphosphatemia in end stage renal failure,

Approved April 2001



Neurology

Axert (almotriptan malate) tablets; Pharmacia; For the treatment of migraine attacks, Approved May 2001

Bayer Extra Strength Asprin; Bayer; Oral treatment for mild to moderate migraine pain, Approved October 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD),

















































Frova (frovatriptan succinate); Elan Pharmaceuticals; Tablets for the acute treatment of migraine attacks, Approved

November 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved

April 2001

Reminyl (galantamine hydrobromide); Janssen Pharmaceutica; For the treatment of mild to moderate dementia of the

Alzheimer's type, Approved February 2001

Ultracet (acetaminophen and tramadol HCl); Ortho-McNeil Pharmaceutical; For the short-term management of acute

pain, Approved August 2001

Zomig (zolmitriptan); AstraZeneca; Orally disintegrating tablet for the treatment of acute migraine in adults, Approved

February 2001


Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved

November 2001




Monistat 3 (miconazole nitrate); Advanced Care Products; Emulsion, cream for the treatment of vaginal yeast infections,


NuvaRing; Organon; Monthly vaginal ring for birth control, Approved October 2001

Ortho Evra; Ortho-McNeil Pharmaceutical; Transdermal patch for contraception, Approved November 2001

Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001

Oncology

Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001



Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001
















































Kytril (granisetron) solution; Roche; For the prevention of nausea and vomiting associated with cancer therapy, Approved

June 2001



Xeloda; Roche; Oral chemotherapy for the treatment of metastatic colorectal cancer, Approved May 2001

Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001

Ophthalmology

Lumigan (bimatoprost ophthalmic solution); Allergan; For the reduction of intraocular pressure in patients with open-

angle glaucoma or ocular hypertension, Approved March 2001

Travatan (travoprost ophthalmic solution); Alcon; For the reduction of elevated intraocular pressure in patients with open-

angle glaucoma or ocular hypertension, Approved March 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March

2001


Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder

(ADHD), Approved October 2001






April 2001

NasalCrom Nasal Spray; Pharmacia; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved

April 2001


Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder

(ADHD), Approved October 2001













































April 2001

Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001

Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January

2001

Ziprasidone (ziprasidone hydrochloride); Pfizer; Oral capsule for the treatment of schizophrenia, Approved February

2001


Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of

bacterial infections, Approved November 2001

DuoNeb (albuterol sulfate and ipratropium bromide) ; Dey Laboratories; For the treatment of bronchospasm associated

with COPD, Approved March 2001

Foradil Aerolizer (formoterol fumarate inhalation powder); Novartis; Bronchodilator for COPD, asthma and

bronchospasm, Approved February 2001 (asthma, bronchospasm); September 2001 (COPD)


NasalCrom Nasal Spray; Pharmacia; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved

April 2001

Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic

rhinitis, and the common cold, Approved March 2001

Tracleer (bosentan); Actelion; For the treatment of pulmonary arterial hypertension, Approved November 2001

Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm,

Approved April 2001

Rheumatology

Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved

November 2001

Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001
















































Remicade (infliximab); Centocor; For inhibiting the progression of structural damage in patients with rheumatoid arthritis,


Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January

2001

2000


Angiomax (bivalirudin); The Medicines Company; For patients with unstable angina

undergoing percutaneous transluminal coronary angioplasty (PTCA), Approved December 2000

Argatroban Injection; Texas Biotechnology Corporation, SmithKline Beecham; Anticoagulant

for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.,

Approved June 2000

Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved

September 2000

Betapace AF Tablet; Berlex Laboratories; For treatment of the irregular heartbeats in patients

with atrial fibrillation, Approved February 2000

Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high

blood pressure, Approved January 2000

Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the

treatment of acute symptomatic deep vein thrombosis, Approved July 2000

Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct

to diet to reduce elevated total cholesterol, Approved October 2000

Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the

treatment of hypertension, Approved November 2000

Nitrostat (nitroglycerin) Tablets; Parke-Davis; For the acute relief of an attack or acute

prophylaxis of angina pectoris due to coronary artery disease., Approved May 2000





































Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); Dermik Laboratories; For

the topical treatment of acne vulgaris, Approved November 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July

2000

Chloraprep (chlorhexidine gluconate); MEDI FLEX HOSP PRODUCTS; For use as a patient

preoperative skin preparation, Approved July 2000

Clindamycin phosphate topical gel; Target Research Associates; For once a day treatment of

acne vulgaris, Approved November 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot,

jock itch and ringworm, Approved March 2000

Protopic (tacrolimus) ointment; Fujisawa Healthcare; For short-term and intermittent long-

term treatment of moderate to severe atopic dermatitis, Approved December 2000

Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA); U.S.

Army Medical Research, Material Command; To reduce absorption of chemical warfare agents

through the skin, Approved February 2000

Endocrinology

Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone

replacement therapy for the prevention of osteoporosis and other symptoms associated

w/postmenopause, Approved April 2000

AndroGel testosterone gel; Unimed Pharmaceuticals; For testosterone replacement therapy in

males with testosterone deficiency, Approved February 2000

Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved

September 2000

Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing

controlled ovarian stimulation, Approved August 2000

Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high

blood pressure, Approved January 2000







































Hectorol (Doxercalciferol) Injection; Bone Care International; To reduce iPTH levels in

management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis,

Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and childrenw/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia,

Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I

and type II diabetes mellitus in adults and pediatrics, Approved April 2000

Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct

to diet to reduce elevated total cholesterol, Approved October 2000

Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For thetreatment of hypertension, Approved November 2000

Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormone-

releasing system for intrauterine contraception, Approved December 2000

NovoLog (insulin aspart); Novo Nordisk; An insulin analogue for the treatment of diabetes

mellitus., Approved June 2000

Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the

induction of final follicular maturation and early luteinization in infertile women, ApprovedSeptember 2000

Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research

Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000

Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate

cancer, Approved March 2000

Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal

osteoporosis, Approved August 2000

Gastroenterology

Colazal (balsalazide disodium); Salix Pharmaceuticals; Mild to moderately active ulcerative

colitis, Approved July 2000







































Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome

(IBS) in females with diarrhea-predominant IBS, Approved February 2000

Pepcid Complete; Merck; For use in the relief of heartburn associated with acid indigestion and

sour stomach, Approved October 2000

Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive

esophagitis, Approved February 2000

Visicol Tablet; Inkine Pharmaceutical; For cleansing of the bowel as a preparation for

colonoscopy, in adults 18 years of age and older, Approved September 2000

Hematology

Argatroban Injection; Texas Biotechnology Corporation, SmithKline Beecham; Anticoagulant

for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.,

Approved June 2000

Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the

treatment of acute symptomatic deep vein thrombosis, Approved July 2000

Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia

A, Approved June 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in

patients with chronic kidney disease on dialysis, Approved July of 2000

Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron

deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000


ABREVA (docosanol); AVANIR PHARMACEUTICALS; Cold sore/fever blister, Approved July

2000

Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute

Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved

March 2000


2000







































Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold,


Evoxac; SnowBrand Pharmaceuticals; For the treatment of symptoms of dry mouth in patients

with Sjogren's Syndrome, Approved January 2000

Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection,


Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot,

jock itch and ringworm, Approved March 2000

Lotrisone (clotrimazole/betamethasone diproprionate) lotion; Schering-Plough; For the

topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis,


Malarone (atovaquone; proguanil hydrochloride) Tablet; GlaxoSmithKline; For the treatment

and prevention of Plasmodium falciparum malaria, Approved July 2000

Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August

2000

Rid Mousse; Soltec Research; For the treatment of head, pubic (crab), and body lice, Approved

March 2000

Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of

nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February

2000

Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of

vaginal yeast infections, Approved April 2000

Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the

treatment of HIV-1 infection, Approved November 2000

MusculoskeletalActivella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone









































Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of

osteoarthritis, Approved April 2000

Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position

and neck pain associated with cervical dystonia, Approved December 2000

Nephrology/Urology


2000

Detrol LA (tolterodine tartrate); Pharmacia & Upjohn; For the treatment of overactive bladder

with symptoms of urge urinary incontinence, urgency and frequency, Approved December 2000

Hectorol (Doxercalciferol) Injection; Bone Care International; To reduce iPTH levels in

management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis,

Approved April 2000

Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August

2000

Renagel (sevelamer hydrochloride); GelTex Pharmaceuticals; For the reduction of serum

phosphorus in patients with end-stage renal disease (ESRD), Approved July 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in

patients with chronic kidney disease on dialysis, Approved July of 2000



Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron

deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000



Neurology

Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of

migraine headaches in adults, Approved August 2000







































Exelon (rivastigmine tartrate); Novartis; Indicated for the treatment of mild to moderate

dementia of the Alzheimer's type, Approved April 2000

Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position

and neck pain associated with cervical dystonia, Approved December 2000

Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in

pediatric patients three years of age and older, Approved October 2000

Neurontin (gabapentin) oral solution; Parke-Davis; Treatment of partial seizures in adults

with epilepsy, Approved March 2000

Novantrone (mitoxantrone hydrochloride); Immunex; For reducing neurologic disability

and/or the frequency of clinical relapses in patients with multiple sclerosis, Approved October

2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the

treatment of partial seizures in children (monotherapy for adults), Approved January 2000

Zonegran (zonisamide) Capsules; Dainippon Pharmaceutical; Adjunctive therapy for

treatment of partial seizures in adults with epilepsy, Approved March 2000


Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone



Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing

controlled ovarian stimulation, Approved August 2000

Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormone-

releasing system for intrauterine contraception, Approved December 2000

Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the

induction of final follicular maturation and early luteinization in infertile women, Approved

September 2000

Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of

vaginal yeast infections, Approved April 2000









































Oncology

Mylotarg (gemtuzumab ozogamicin); Wyeth; For the treatment of CD33 positive acute

myeloid leukemia (AML), Approved May 2000



Trisenox (arsenic trioxide); Cell Therapeutics; For the induction of remission and

consolidation in patients with acute promyelocytic leukemia (APL), Approved September 2000



Ophthalmology

Betaxon; Alcon; For lowering IOP in patients with chronic open-angle glaucoma or ocular

hypertension, Approved February 2000

Quixin (levofloxacin); Santen; For treatment of bacterial conjunctivitis, Approved August 2000

Rescula (unoprostone isopropyl ophthalmic solution) 0.15%; Ciba Vision; For the treatment

of open-angle glaucoma or ocular hypertension, Approved August 2000

Visudyne (verteporfin for injection); QLT; For the treatment of wet age-related macular

degeneration (wet AMD), Approved April 2000

Otolaryngology

Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of

migraine headaches in adults, Approved August 2000

Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive

esophagitis, Approved February 2000



2000








































Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia

A, Approved June 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I

and type II diabetes mellitus in adults and pediatrics, Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and children

w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia,

Approved April 2000

Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in

pediatric patients three years of age and older, Approved October 2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the

treatment of partial seizures in children (monotherapy for adults), Approved January 2000


Concerta; Alza; For the treatment of Attention Deficit Hyperactivity Disorder, Approved August

2000


Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute

Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved

March 2000


2000



2000

Rheumatology

Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of

osteoarthritis, Approved April 2000































us fda approved drug list

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