New and Generic Drug Approvals

May 24, 2013

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Calcitriol calcitriolCapsule; Oral Banner PharmacapsApproval
Haldol haloperidol decanoateInjectable; Injection Janssen PharmsManufacturing Change or Addition
Humatrope somatropin recombinantInjectable; Injection LillyManufacturing Change or Addition
Kombiglyze Xr metformin hydrochloride; saxagliptin hydrochlorideTablet, Extended Release; Oral Bristol Myers SquibbEfficacy Supplement with Clinical Data to Support
Luvox fluvoxamine maleateTablet; Oral Ani PharmsManufacturing Change or Addition
Nasacort Aq triamcinolone acetonideSpray, Metered; Nasal Sanofi Aventis UsManufacturing Change or Addition
Onglyza saxagliptin hydrochlorideTablet; Oral Bristol Myers SquibbEfficacy Supplement with Clinical Data to Support
Plavix clopidogrel bisulfateTablet; Oral Sanofi Aventis UsManufacturing Change or Addition
Stimate desmopressin acetateSpray, Metered; Nasal Csl BehringLabeling Revision
Stimate (Needs No Refrigeration) desmopressin acetateSpray, Metered; Nasal Csl BehringLabeling Revision
Trospium Chloride trospium chlorideCapsule; Oral Paddock LlcApproval
Tysabri natalizumabVial; Single-Use Biogen IdecLabeling Revision

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