New and Generic Drug Approvals

May 24, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Calcitriol	calcitriol	Capsule; Oral	Banner Pharmacaps	Approval
Haldol	haloperidol decanoate	Injectable; Injection	Janssen Pharms	Manufacturing Change or Addition
Humatrope	somatropin recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Kombiglyze Xr	metformin hydrochloride; saxagliptin hydrochloride	Tablet, Extended Release; Oral	Bristol Myers Squibb	Efficacy Supplement with Clinical Data to Support
Luvox	fluvoxamine maleate	Tablet; Oral	Ani Pharms	Manufacturing Change or Addition
Nasacort Aq	triamcinolone acetonide	Spray, Metered; Nasal	Sanofi Aventis Us	Manufacturing Change or Addition
Onglyza	saxagliptin hydrochloride	Tablet; Oral	Bristol Myers Squibb	Efficacy Supplement with Clinical Data to Support
Plavix	clopidogrel bisulfate	Tablet; Oral	Sanofi Aventis Us	Manufacturing Change or Addition
Stimate	desmopressin acetate	Spray, Metered; Nasal	Csl Behring	Labeling Revision
Stimate (Needs No Refrigeration)	desmopressin acetate	Spray, Metered; Nasal	Csl Behring	Labeling Revision
Trospium Chloride	trospium chloride	Capsule; Oral	Paddock Llc	Approval
Tysabri	natalizumab	Vial; Single-Use	Biogen Idec	Labeling Revision