CDER New September 18, 2014

What's New on the FDA Drugs Site

September 17, 2014

• Drugs@FDA Data Files (updated)
• Drug Registration and Listing System (DRLS & eDRLS) (updated)
• Electronic Drug Registration and Listing Instructions (updated)
• Small Business and Industry Education Series 
  • Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND
• Warning Letters 2014 (updated)

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New and Generic Drug Approvals

September 16, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Ambisome	amphotericin b	Injectable, Liposomal;Injection	Astellas	Manufacturing Change or Addition
Complera	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	Tablet;Oral	Gilead Sciences Inc	Labeling Revision
Fortical	calcitonin salmon recombinant	Spray, Metered;Nasal	Upsher Smith	Manufacturing Change or Addition
Movantik	naloxegol	Tablet, Tablet;Oral	Astrazeneca Pharms	Approval
Tegretol	carbamazepine	Tablet;Oral	Novartis	Labeling Revision
Tegretol	carbamazepine	Tablet, Chewable;Oral	Novartis	Labeling Revision
Tegretol	carbamazepine	Suspension;Oral	Novartis	Labeling Revision
Tegretol-Xr	carbamazepine	Tablet, Extended Release;Oral	Novartis	Labeling Revision
Tobramycin Sulfate	tobramycin sulfate	Injectable;Injection	Akorn	Approval
Tobramycin Sulfate	tobramycin sulfate	Injectable;Injection	Xellia Pharms Aps	Approval
Varithena	polidocanol	Solution;Intravenous	Provensis	Manufacturing Change or Addition

 

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