USFDA: New and Generic Drug Approvals: 20 OCT 2014

New and Generic Drug Approvals

October 20, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Absorica isotretinoin Capsule;Oral Ranbaxy Manufacturing Change or Addition
Afinitor everolimus Tablet;Oral Novartis Manufacturing Change or Addition
Boniva ibandronate sodium Injectable;Intravenous Roche Manufacturing Change or Addition
Cleocin Phosphate clindamycin phosphate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Dutoprol hydrochlorothiazide; metoprolol succinate Tablet, Extended Release;Oral Covis Pharma Sarl Labeling Revision
Nexium Iv esomeprazole sodium Injectable;Intravenous Astrazeneca Manufacturing Change or Addition
Tarka trandolapril; verapamil hydrochloride Tablet, Extended Release;Oral Abbvie Manufacturing Change or Addition
Xiaflex collagenase clostridium histolyticum Solution; Injection Auxilium Pharms Efficacy Supplement with Clinical Data to Support

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