Download - US FDA panel drug approval recommendations
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US FDA panel drug approval recommendations
Dual therapies for H. pylori eradication endorsed The US FDA's advisory committees on anti-infective
and gastrointestinal drugs have recommended the approval of two types of dual-therapy for the eradication of Helicobacter pylori infection in patients with peptic ulcer disease, reports the Wall Street Journal. I
These therapies are clarithromycin ['Biaxin'; Abbon Laboratories] + omeprazoJe ('Prilosec'; Astra Merck Inc.1, and c1arithromycin + ranitidine bismutrex ['Tritec'; Glaxo Wellcome]. However. the comminees recommended against the approval of ranitidine bismutrex + amoxicillin as data on the efficacy of this combination therapy were inconclusive.
Reoommendatiom for ophtbahnic products Pharmacia & Upjohn's topical prostaglandin
Iatanoprost ['Xalatan'] has been recommended for approvaJ by the FDA's Ophthalmic Drugs Subcommittee for the reduction of intraocular pressure in patients with open-angle glaucoma and ocular hypertension, according to the Pink Shut. 2
The subcommiuee voted 4-2 to recommend the approval of Iatanoprost; the 2 votes against approval were due to the risk of iridial pigmentation associated with use of the drug. Pharmacia & Upjohn plan to assess the risk of iridial pigmentation in 4 postmarketing studies.
The FDA's Ophthalmic and Dermatologic Advisory Committee has recommended the approval of Chiron Vi sion's sterile intravitreal ganciclovir implant· 'Vitrasert ' in patients with cytomegalovirus (CMV) retinitis.) In a study involving patients with newlydiagnosed AIDS-related CMV retinitis, the agent delayed time to progression of the disease by 112 days, compared with IV ganciclovir.·
"The implant is p/Qcai irI the posterior segnv:nr of the <rye and deJivus gondcluW for up (Q 8 rtIQtIlJu.
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pi&memation 10 be uaaaod ill row- poIt·marketia, swdie&; IIpp"OV:Il ~ by FDA Advisory Cocnminee. FDC Reports - Pink SbceI -f'raa"iptitIII ~ IIId Bicnd>noIoc: 8, II Dec 1m 3. 0Iir0D VJtrUUI tilDe 10 ~ is 194 dI)'I ill phase m IriaI; opbthalrrlie impIaDt IO::Ww:c:ndo>d for awrovaI by FDA Advitary Comrninee. FDC Reports - Pink SbceI - PretaipioD I'ba-mIceuIicab aDd B~ 7. II Dc<: 1m _ ,_
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