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Keeping Up-to-Date, with so
Little Time: Newly Approved
Medication Review
Golden L. Peters, PharmD, BCPS
Associate Professor, Pharmacy Practice Department
St. Louis College of Pharmacy
Dr. Peters declares no conflicts of interest, real or apparent, and no
financial interests in any company, product, or service mentioned in
this program, including grants, employment, gifts, stock holdings and
honoraria.
Disclosures and Conflict of Interest
At the conclusion of this program, the pharmacist will be able to:
1. Identify new molecular and biological entities that entered the U.S. drug market in the past year (excluding diagnostic compounds)
2. Describe each agent’s mechanism of action, dosage, adverse reactions, contraindications, and drug interaction profile
3. Recognize special instructions and monitoring parameters for each agent
4. Identify molecular entities that have been approved as generic medications by the FDA in the past year
Pharmacist Objectives
At the conclusion of this program, the pharmacy technician will be
able to:
1. Identify new molecular and biological entities that entered the U.S.
drug market in the past year (excluding diagnostic compounds)
2. Describe each agent’s mechanism of action, dosage, adverse
reactions, contraindications, and drug interaction profile
3. List special instructions and monitoring parameters for each agent
4. Identify molecular entities that have been approved as generic
medications by the FDA in the past year
Technician Objectives
1. What is the recommended starting dose for ertugliflozin?
A. 2.5 mg PO daily
B. 5 mg PO daily
C. 10 mg PO daily
D. 15 mg PO daily
Pre-Test Questions
2. What medical indication was sarilumab approved for?
A. Plaque psoriasis
B. Rheumatoid arthritis
C. Hyperlipidemia
D. Hepatitis C
Pre-Test Questions
3. What is the mechanism of action for naldemedine?
A. Opioid antagonist with binding affinities for mu-, delta-, and
kappa-opioid receptors
B. Unknown
C. Human monoclonal antibody that binds to IL-6 receptors, reduces
inflammatory cytokines
D. Oral factor Xa inhibitor that selectively blocks the active site of
FXa
Pre-Test Questions
4. What is the recommend storage procedure for guselkumab?
A. Store at room temperature
B. Shake vial to reconstitute
C. Protect from light
D. Must store in original packaging
Pre-Test Questions
Newly approved medications
New dosage formulations and combinations
Recent generics
Upcoming generics
Products removed from market
Outline
3A4 inhibitors:
Amiodarone
Cimetidine
Clarithromycin
Diltiazem
Erythromycin
grapefruit juice
Ketoconazole
Verapamil
CYP P450 Substrates
• 3A4 inducers:
• Carbamazepine
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Pioglitazone
• Rifampin
• Topiramate
• St. John’s wort
• 2D6 inhibitors:
• Amiodarone
• Bupropion
• Diphenhydramine
• Fluoxetine
• Haloperidol
• Paroxetine
• Terbinafine
• Chloroquine
Lexi-Comp, Inc. (Lexi-Drugs® ). Lexi-Comp, Inc.; May 3, 2018
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM536693.pdf
To date in 2018 →
Indication:
Indicated for cholera prevention for travelers ages 18 – 64 visiting areas
with active cholera transmission
Only vaccine available to prevent cholera at this time
Mechanism of Action:
Vaccine contains live attenuated cholera bacteria that replicate in the
gastrointestinal tract of the recipient to provide immunity
Dosing:
Single dose, live attenuated oral vaccine
Administered 10 days or more before travel
Duration of coverage is unknown
(3 – 6 months)
Cholera vaccine (Vaxchora™)
U.S Food and Drug Administration, 2016,
https://www.paxvaxconnect.com/PDF/Vaxchora_Prescribing_Information.pdf
Precautions:
Immunocompromised persons
Adverse Reactions:
Mild headache (18.9%)
Mild tiredness (18.7%)
Mild nausea/vomiting (13.3%)
Mild abdominal pain (12.1%)
Moderate tiredness (12%)
Decreased appetite, mild (11.7%)
Cholera vaccine (Vaxchora™)
U.S Food and Drug Administration, 2016,
https://www.paxvaxconnect.com/PDF/Vaxchora_Prescribing_Information.pdf
Source: ttp://www.who.int/gho/epidemic_diseases/cholera/epidemics/en/
Indication:
Treatment of opioid-induced constipation in adults with chronic
noncancer pain
Mechanism of action:
Opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid
receptors
Peripherally acting mu-opioid receptor antagonist in the GI tract,
decreasing the constipating effects of opioids
Dosing:
Schedule II
0.2 mg PO qDay
Naldemedine (Symproic™)
U.S Food and Drug Administration, 2017,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf
Contraindications
Known or suspected GI obstruction
Precautions
Gastrointestinal perforation
Crohn disease
Opioid withdrawal
Administration
Discontinue naldemedine if treatment with opioids is also discontinued
Naldemedine (Symproic™)
U.S Food and Drug Administration, 2017,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf
Adverse Reactions
Abdominal pain (8-11%)
Diarrhea (7%)
Nausea (4-6%)
Vomiting (3%)
Drug interaction overview
Strong CYP3A4 inducers → decreased efficacy of naldemedine
Moderate or strong CYP3A4 inhibitors → increased naldemedine
concentrations
P-gp inhibitors → increased naldemedine concentrations
Avoid use with another opioid antagonist
Naldemedine (Symproic™)
U.S Food and Drug Administration, 2017,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf
Indication:
Treatment of adults with tardive dyskinesia
Mechanism of action:
Unknown
Dosing:
40 mg PO qDay x1 week, then
Increase to 80 mg PO qDay
Hepatic impairment
Moderate-to-severe (Child-Pugh 7-15)
Not to exceed 40 mg/day
Renal impairment
Severe (CrCl <30 mL/min)
Use not recommended
Valbenazine (Ingrezza™)
U.S Food and Drug Administration, 2017,
https://ingrezza.com/HCP/PI
Precautions
Warn patients not to perform activities requiring mental alertness d/t
somnolence
QT prolongation
Not clinically significant at recommending dosing
Coadministration with strong CYP2D6 or 3A4 inhibitors may lead to
clinically significant QT prolongation
Valbenazine (Ingrezza™)
U.S Food and Drug Administration, 2017,
https://ingrezza.com/HCP/PI
Drug Interactions
Strong CYP3A4 inducers
Coadministration not recommended
Strong CYP3A4 inhibitors
Reduce valbenazine dose to 40 mg/day
Strong CYP2D6 inhibitors
Reduce valbenazine dose to 40 mg/day
Valbenazine (Ingrezza™)
U.S Food and Drug Administration, 2017,
https://ingrezza.com/HCP/PI
Adverse Reactions
Somnolence (10.9%)
Anticholinergic effects (5.4%)
Balance disorders/fall (4.1%)
Headache (3.4%)
Akathisia (2.7%)
Vomiting (2.6%)
Valbenazine (Ingrezza™)
U.S Food and Drug Administration, 2017,
https://ingrezza.com/HCP/PI
Indication:
Indicated for adults with moderate - severe RA
With inadequate response or intolerance to ≥1 disease-modifying antirheumatic
drugs (DMARDs)
Mechanism of action:
Human monoclonal antibody that binds to IL-6 receptors, reduces inflammatory
cytokines
Dosing:
200 mg subcut q2wk (prefilled syringe)
Sarilumab (Kevzara™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
Drug interactions
Avoid use with live virus vaccines
Dosing considerations
Assess platelet count prior to initiation and monitor platelets 4 to 8 weeks
after start of therapy and every 3 months thereafter
Initiation not recommended with:
ANC <2000/mm³
Platelets <150,000/mm³
ALT or AST >1.5 x ULN
Test for tuberculosis before initiating
Sarilumab (Kevzara™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
Boxed warning:
Increases risk for developing serious infections that may lead to hospitalization or death
Opportunistic infections reported
Avoid use in patients with active infection
Precautions:
Immunosuppression may result in an increased risk of malignancies
Not recommended with active hepatic disease or hepatic impairment
Sarilumab (Kevzara™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
Adverse Reactions:
ALT >ULN to ≤3 x ULN (38-43%)
AST >ULN to ≤3 x ULN (27-30%)
Injection site reaction (7%)
ANC <1000 cells/³ (4-6%)
Sarilumab (Kevzara™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
Indication:
Skin and skin structure infections
Mechanism of action:
Fluoroquinolone antibiotic: inhibits both bacterial topoisomerase IV and
DNA gyrase enzymes, which are required for bacterial DNA replication,
transcription, repair, and recombination
Dosing:
300 mg IV q12hr for 5-14 days, OR
300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-14 days,
OR
450 mg PO q12hr for 5-14 days
Delafloxacin (Baxdela™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf
Boxed warning:
Fluoroquinolones have been associated with tendinitis and tendon
rupture, peripheral neuropathy, and CNS effects
Drug interactions:
Fluoroquinolones form chelates with:
Antacids containing aluminum or magnesium
Sucralfate
Iron
Multivitamins containing iron or zinc
Administer delafloxacin at least 2 hr before or 6 hr after antacids
or multivitamins containing Mg, Al, Fe, or Zn
Delafloxacin (Baxdela™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf
Precautions:
Fluoroquinolones are associated with increased risk of peripheral
neuropathy
Adverse Reactions:
Nausea (8%)
Diarrhea (8%)
Delafloxacin (Baxdela™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf
Indication:
Prophylaxis of VTE in adults hospitalized for acute medical illness who are
at risk for thromboembolic complication
Mechanism of action:
Oral factor Xa inhibitor that selectively blocks the active site of FXa
By directly inhibiting FXa, betrixaban decreases thrombin generation
Coagulation cascade is dependent upon the activation of factor X to FXa
Betrixaban (Bevyxxa™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf
Dosing:
Initial single dose: 160 mg PO, THEN 80 mg PO qDay
Recommended duration of treatment: 35-42 days
CrCl ≥15 to <30 mL/min: Initial single dose of 80 mg, then 40 mg PO qDay
x35-42 days
Boxed warning:
Epidural or spinal hematomas may occur (anesthesia patients)
Contraindications:
Active pathological bleeding
Betrixaban (Bevyxxa™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf
Precautions:
No established way to reverse betrixaban’s anticoagulant effect
Can persist for at least 72 hr after the last dose
Adverse Reactions:
Clinically relevant non-major bleeding (2.45%)
Epistaxis (2%)
Hematuria (2%)
Betrixaban (Bevyxxa™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf
Indication:
Indicated for moderate-to-severe chronic plaque psoriasis
Mechanism of action:
Monoclonal antibody that inhibits IL-23, inhibiting the proinflammatory
actions of IL-23
Dosing:
100 mg subcut at week 0, week 4, and q8wk thereafter
Drug interactions
Avoid use of live vaccines
Guselkumab (Tremfya™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
Contraindications:
None
Precautions:
May increase infection risk
Screen for tuberculosis
Adverse Reactions:
Infections, general (23%); compared with 21% in placebo group
Upper respiratory tract infections (14.3%)
Headache (4.6%)
Injection site reactions (4.5%)
Guselkumab (Tremfya™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
Administration:
Remove from refrigerator; allow syringe to reach room temperature (~30
min) before removing syringe cap
For subcut use only; each prefilled syringe is single dose only; inject full
amount
Storage:
Store refrigerated at 2-8°C (36-46°F)
Protect from light until use
Do not freeze
Do not shake
Guselkumab (Tremfya™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
Indication:
Add-on maintenance treatment of severe asthma, with an eosinophilic
phenotype aged ≥12 years
Mechanism of action:
Interleukin-5 receptor monoclonal antibody
IL-5 receptor is expressed on the surface of eosinophils and basophils
Reduces eosinophils and basophils through cell-mediated cytotoxicity
Dosing:
30 mg subcut q4weeks for the first 3 doses, THEN q8weeks
Contraindications:
None
Benralizumab (Fasenra™)
U.S Food and Drug Administration, 2018,
https://www.azpicentral.com/fasenra/fasenra_pi.pdf
Precautions:
Hypersensitivity reactions
Avoid use in acute asthma symptoms or acute exacerbations
Adverse Reactions:
Headache (8%)
Pharyngitis (5%)
Benralizumab (Fasenra™)
U.S Food and Drug Administration, 2018,
https://www.azpicentral.com/fasenra/fasenra_pi.pdf
Administration:
Prior to administration, warm by leaving carton at room temperature for
about 30 minutes
Once removed from refrigerator, administer within 24 hr or discard
For subcutaneous use only
Administer subcut in upper arm, thigh, or abdomen
Storage:
Refrigerate at 2-8°C (36-46°F)
Store in the original carton to protect from light
Do not freeze
Do not shake
Benralizumab (Fasenra™)
U.S Food and Drug Administration, 2018,
https://www.azpicentral.com/fasenra/fasenra_pi.pdf
Indication:
Bacterial vaginosis for adult women
Mechanism of action:
Secnidazole is a nitroimidazole derivative
5-nitroimidazoles enters the bacterial cell, the nitro group is turned into
radical anions
These radical anions interfere with bacterial DNA synthesis of susceptible
isolates
Dosing:
1 packet (2 grams) of granules PO qDay, without regard to timing of meals
Secnidazole (Solosec™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf
Precautions:
Vulvovaginal candidiasis may occur
Symptomatic infections may require treatment with an antifungal agent
Carcinogenicity has been seen in mice and rats treated long term with
nitroimidazole derivatives, avoid long-term use of secnidazole
Adverse Reactions:
Vulvovaginal candidiasis (8.4-9.6%)
Nausea (3.6-5.3%)
Headache (3.6%)
Diarrhea (2.5%)
Vomiting (2.5%)
Secnidazole (Solosec™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf
Administration:
Sprinkle entire contents of the packet onto applesauce, yogurt, or
pudding
Take all the mixture within 30 minutes without chewing or crunching the
granules
Not intended to be dissolved in any liquid
Take 1 entire packet at one time
May be taken without regard to the timing of meals
Pregnancy:
Data regarding use in pregnant women are insufficient
Secnidazole (Solosec™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf
Indication:
reduction of elevated intraocular pressure (IOP) in patients with open-
angle glaucoma or ocular hypertension
Mechanism of action:
Dual inhibitor of Rho kinase and the norepinephrine plasma membrane
transport protein
Dosing:
Instill 1 drop in the affected eye(s) qDay in the evening
Netarsudil ophthalmic
(Rhopressa™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf
Adverse Reactions
Hyperemia (53%)
Blurred vision
Increased lacrimation
Erythema of eyelid
Administration:
remove contact lenses prior to instilling ophthalmic solution
may reinsert contact lenses 15 minutes following its administration
Netarsudil ophthalmic
(Rhopressa™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf
Indication:
adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus
Mechanism of action:
Glucagon-like peptide-1 (GLP-1) agonist
enhance glucose-dependent insulin secretion by pancreatic beta-cells,
suppresses inappropriately elevated glucagon secretion
slows gastric emptying
Semaglutide (Ozempic™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
Dosing:
0.25 mg subcut qWeek for 4 weeks initially; THEN increase the dosage to 0.5 mg qWeek
If glycemic control not achieved after at least 4 weeks on 0.5-mg dose, can increase to 1 mg
qWeek
Precautions:
History of pancreatitis – consider other options
Not indicated for type 1 diabetes mellitus
Postmarket reports of AKI
Adverse Reactions:
Nausea (15.8-20.3%)
Hypoglycemia (16.7-29.8%)
Semaglutide (Ozempic™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
Administration:
Administer subcut to abdomen, thigh, or upper arm
Administer once weekly, on the same day each week, at any time of the
day
Use a different injection site each week
Storage
Unused pens
Refrigerate
After first use
room temperature
Semaglutide (Ozempic™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
Boxed Warning:
In rodents, semaglutide caused dose-dependent and treatment duration
dependent thyroid C-Cell tumors
Unsure of relevance to human population
Semaglutide (Ozempic™)
Adlyxin™ - lixisenatide
Bydureon® - exenatide injectable solution
Byetta® - exenatide injectable suspension
Ozempic® - semaglutide
Saxenda® - liraglutide
Tanzeum® - albiglutide
Trulicity® - dulaglutide
Victoza® - liraglutide
Xultophy® - liraglutide/insulin degludec
Glucagon-like peptide-1 (GLP-1) agonist
Lexi-Comp, Inc. (Lexi-Drugs® ). Lexi-Comp, Inc.; August 17, 2017
Indication:
Adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus
Mechanism of action:
Selective sodium-glucose transporter-2 (SGLT2) inhibitor
lowers the renal glucose threshold → increased urinary glucose
Dosing:
Recommended starting dose is 5 mg PO qDay in the morning
Maximum of 15 mg qDay
eGFR ≥60 mL/min/1.73 m²: No dosage adjustment necessary
eGFR <30 mL/min/1.73 m²: Contraindicated
Ertugliflozin (Steglatro™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf
Adverse Reactions:
Female genital fungal infections (9.1-12.2%)
Volume depletion adverse effects (1.9-4.4%)
Urinary tract infections (4-4.1%)
Ertugliflozin (Steglatro™)
U.S Food and Drug Administration, 2018,
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf
Canagliflozin - Invokana®
Dapagliflozin - Farxiga®
Empagliflozin - Jardiance®
Selective sodium-glucose transporter-2
(SGLT2) inhibitor
Lexi-Comp, Inc. (Lexi-Drugs® ). Lexi-Comp, Inc.; August 17, 2017
Vancomycin
Firvanq
oral solution formulation for C. difficile-associated diarrhea
Benzhydrocodone/APAP
Apadaz
Acute pain
Lamivudine/tenofovir disoproxil fumarate
Cimduo
HIV combination therapy
Amantadine
Osmolex ER
ER formulation
New Dosage Forms
Efavirenz/lamivudine/tenofovir
disoproxil fumarate
Symfi
HIV combination therapy (higher
strength efavirenz than Symfi Lo)
Lidocaine patch
Ztlido
Post-herpetic neuralgia
Cocaine
Coprelto
Intranasal local anesthetic for
diagnostic or surgical procedures
or nasal cavities
U.S Food and Drug Administration, 2018,
http://pharmacistsletter.therapeuticresearch.com/pl/NewDrugs.aspx?cs=FACULTY
&s=PL&pt=20&yr=2018
Arymo ER® (morphine)
Extended-release tablets for severe pain
Noctiva™ (desmopressin)
New nasal spray formulation for nocturia due to nocturnal polyuria
Vantrela ER® (hydrocodone)
Extended release tablets for severe pain
Consensi™ (amlodipine/celecoxib)
Hypertesion/OA combination product
New Dosage Forms
U.S Food and Drug Administration, 2017,
Eletriptan (Relpaz™)
Oseltamivir (Tamiflu®)
Prasugrel (Effient®)
Sildenafil (Viagra®)
Testosterone (AndroGel®)
Sumatriptan/Naproxen (Treximet™)
Cinacalcet (Sensipar®)
Etanercept (Enbrel®)
Tadalafil (Cialis®) (September 2018)
Vardenafil (Levitra®) (3rd quarter 2018)
Pregabalin (December 2018)
Lurasidone (Lutuda™) (January2019)
Pregabalin (Lyrica®) (July 2019)
Recent Generics
U.S Food and Drug Administration, 2018,
http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?cs=FACULTY
&s=PL&dd=290111&pb=&pt=2&fpt=55&menu=ftg
Drugs Withdrawn from Market –
2015 - 2018
Elepsia XR
Levetiracetam extended release
FDA revoked approval
Manufacturing quality problems
Opana ER
Oxymorphone
Benefit no longer outweigh
risk
Zinbryta
Daclizumab
safety concerns
severe liver damage and
immune-related conditions
U.S Food and Drug Administration, 2018,
1. What is the recommended starting dose for ertugliflozin?
A. 2.5 mg PO daily
B. 5 mg PO daily
C. 10 mg PO daily
D. 15 mg PO daily
Pre-Test Questions
2. What medical indication was sarilumab approved for?
A. Plaque psoriasis
B. Rheumatoid arthritis
C. Hyperlipidemia
D. Hepatitis C
Pre-Test Questions
3. What is the mechanism of action for naldemedine?
A. Opioid antagonist with binding affinities for mu-, delta-, and
kappa-opioid receptors
B. Unknown
C. Human monoclonal antibody that binds to IL-6 receptors, reduces
inflammatory cytokines
D. Oral factor Xa inhibitor that selectively blocks the active site of
FXa
Pre-Test Questions
4. What is the recommend storage procedure for guselkumab?
A. Store at room temperature
B. Shake vial to reconstitute
C. Protect from light
D. Must store in original packaging
Pre-Test Questions
• There were 46 NME approved in 2017, there have been ___
NME approved in 2018
• New medications are constantly being reviewed and approved
by the FDA
• This changes the treatment options for patients and
prescribers
• As providers we must be vigilant to keep up with these new
medications and at the very least know where to quickly find
information related to new medications
Take Home Points
Resources & References
FDA New Drug Innovation webpage:
• https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm
CenterWatch webpage for newly approved medications
• http://www.centerwatch.com/drug-information/fda-approved-drugs/
Pharmacist Letter webpage for newly approved medications
• http://pharmacistsletter.therapeuticresearch.com/pl/NewDrugs.aspx?cs=FACULTY&s=PL
Package Inserts:
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM506235.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf
www.ingrezza.com/HCP/PI
www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
www.azpicentral.com/fasenra/fasenra_pi.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/208254lbl.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf
Resources & References
Questions?
Keeping Up-to-Date, with so
Little Time: Newly Approved
Medication Review
Golden L. Peters, PharmD, BCPS
Associate Professor, Pharmacy Practice Department
St. Louis College of Pharmacy
Golden.Peters@stlcop.edu
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