CDER New November 19, 2014

What's New on the FDA Drugs Site

November 18, 2014

• Current Projects (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages: New and Updated
  • Trypan Blue (Membraneblue) (New - Currently in Shortage)
  • Vancomycin Hydrochloride for Injection, USP (New - Currently in Shortage)
• Guidance for Industry:
  • Vaginal Microbicides: Development for the Prevention of HIV Infection (PDF - 352KB)
  • Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
  • Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 136KB)
• National Drug Code Directory
• Public Meeting on Chagas Disease Patient-Focused Drug Development, April 28, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD. Meeting information

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New and Generic Drug Approvals

November 17, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cutivate	fluticasone propionate	Lotion;Topical	Fougera Pharms	Manufacturing Change or Addition
Hepatamine 8%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Nucynta	tapentadol hydrochloride	Solution;Oral	Janssen Pharms	Labeling Revision
Pegintron	peginterferon alfa-2b	Syringe	Schering	Labeling Revision
Pegintron	peginterferon alfa-2b	Vial	Schering	Labeling Revision
Sylatron	peginterferon alfa-2b	Vial	Schering	Labeling Revision
Unasyn	ampicillin sodium; sulbactam sodium	Injectable;Injection	Pfizer	Labeling Revision

 

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— Wednesday, November 19, 2014 — Add Comment