USFDA: New and Generic Drug Approvals: 19 SEP 2014

New and Generic Drug Approvals

September 19, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ammonia N 13 Injectionammonia n 13 injectionInjectable;InjectionShertech Labs LlcApproval
Chantixvarenicline tartrateTablet;OralPfizer IncEfficacy Supplement with Clinical Data to Support
Chantixvarenicline tartrateTablet;OralPfizer IncLabeling Revision
Janumet Xrmetformin hydrochloride; sitagliptin phosphateTablet, Extended Release;OralMerck Sharp DohmeManufacturing Change or Addition
LexiscanregadenosonSolution;IntravenousAstellasLabeling Revision
LumiganbimatoprostSolution/Drops;OphthalmicAllerganManufacturing Change or Addition
Marcainebupivacaine hydrochlorideInjectable;SpinalHospiraManufacturing Change or Addition
Marcaine Hydrochloridebupivacaine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride Preservative Freebupivacaine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrinebupivacaine hydrochloride; epinephrine bitartrateInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrine Preservative Freebupivacaine hydrochloride; epinephrine bitartrateInjectable;InjectionHospiraManufacturing Change or Addition
Nasacort Allergy 24 Hourtriamcinolone acetonideSpray, Metered;NasalSanofi Aventis UsLabeling Revision
OtezlaapremilastTablet;OralCelgene CorpManufacturing Change or Addition
PentostatinpentostatinInjectable;InjectionMylan InstitutionalApproval
Rizatriptan Benzoaterizatriptan benzoateTablet, Orally Disintegrating;OralMacleods Pharms LtdApproval
TemodartemozolomideCapsule;OralMerck Sharp DohmeManufacturing Change or Addition

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