USFDA: New and Generic Drug Approvals: 28 AUG 2014

New and Generic Drug Approvals

August 28, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aleve Pmdiphenhydramine hydrochloride; naproxen sodiumTablet;OralBayer HlthcareLabeling Revision
Avonexinterferon beta-1aVialBiogenLabeling Revision
DecitabinedecitabineInjectable;InjectionSandoz IncApproval
Ellaulipristal acetateTablet;OralLab Hra PharmaLabeling Revision
Frovatriptan Succinatefrovatriptan succinateTablet;OralMylan Pharms IncApproval
IfexifosfamideInjectable;InjectionBaxter HlthcareLabeling Revision
Ifex/Mesnex Kitifosfamide; mesnaInjectable;InjectionBaxter HlthcareLabeling Revision
Lamivudine and Zidovudinelamivudine;zidovudineTablet;OralMylan Pharms IncApproval
Metformin Hydrochloridemetformin hydrochlorideTablet;OralZydus HlthcareApproval
Oxycodone; Acetaminophenoxycodone;acetaminophenTablet;OralRhodes PharmsApproval
Requipropinirole hydrochlorideTablet;OralGlaxosmithkline LlcLabeling Revision
Requip Xlropinirole hydrochlorideTablet, Extended Release;OralGlaxosmithkline LlcLabeling Revision
Rimso-50dimethyl sulfoxideSolution;IntravesicalMylan InstitutionalManufacturing Change or Addition
Stavzorvalproic acidCapsule, Delayed Release;OralBanner PharmacapsLabeling Revision
Stribildcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTablet;OralGilead Sciences IncEfficacy Supplement with Clinical Data to Support

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