New and Generic Drug Approvals

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Avandamet metformin hydrochloride; rosiglitazone maleateTablet;Oral Sb PharmcoLabeling Revision
Avandaryl glimepiride; rosiglitazone maleateTablet;Oral Sb PharmcoLabeling Revision
Avandia rosiglitazone maleateTablet;Oral Sb PharmcoLabeling Revision
Benicar Hct hydrochlorothiazide; olmesartan medoxomilTablet;Oral Daiichi SankyoManufacturing Change or Addition
Botox onabotulinumtoxinaVial; Single-Use AllerganLabeling Revision
Botox Cosmetic onabotulinumtoxinaVial; Single-Use AllerganLabeling Revision
Kynamro mipomersen sodiumSolution;Subcutaneous Genzyme CorpLabeling Revision
Pantoprazole Sodium pantoprazole sodiumTablet, Delayed Release;Oral Perrigo R and DApproval
Rosiglitazone Maleate; Metformin Hydrochloride rosiglitazone maleate; metformin hydrochlorideTablet; Oral Teva PharmsApproval
Xeljanz tofacitinib citrateTablet;Oral Pf Prism CvLabeling Revision

 

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