New and Generic Drug Approvals

July 2, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Actemra	tocilizumab	Injectable; Injection	Genentech	Labeling Revision
Efudex	fluorouracil	Cream; Topical	Valeant Pharm Intl	Manufacturing Change or Addition
Efudex	fluorouracil	Solution; Topical	Valeant Pharm Intl	Manufacturing Change or Addition
Nasacort Aq	triamcinolone acetonide	Spray, Metered; Nasal	Sanofi Aventis Us	Efficacy Supplement with Clinical Data to Support
Pegasys	peginterferon alfa-2a	Syringe	Hoffman-La Roche	Labeling Revision
Pegasys	peginterferon alfa-2a	Vial; Subcutaneous	Hoffman-La Roche	Labeling Revision
Rosuvastatin Calcium	rosuvastatin calcium	Tablet; Oral	Mylan Pharma	Tentative Approval
Sprix	ketorolac tromethamine	Spray, Metered; Nasal	Luitpold	Manufacturing Change or Addition
Ziana	clindamycin phosphate; tretinoin	Gel; Topical	Medicis	Manufacturing Change or Addition