CDER New October 6, 2015

What's New on the FDA Drugs Site

October 5, 2015

• Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (PDF - 231KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Chloroquine Phosphate Tablets   (Updated - Currently in Shortage)
  • Metoprolol Injection (New - Discontinuation)
  • Metoprolol Injection   (Updated - Currently in Shortage)
  • Mometasone Furoate Monohydrate (Nasonex)  (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
• National Drug Code Directory

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New and Generic Drug Approvals

October 2, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Ativan	lorazepam	Injectable;Injection	Eurohlth Intl Sarl	Manufacturing Change or Addition
Copaxone	glatiramer acetate	For Solution;Subcutaneous	Teva Pharms Usa	Manufacturing Change or Addition
Copaxone	glatiramer acetate	Injectable;Subcutaneous	Teva Pharms Usa	Manufacturing Change or Addition
Coreg	carvedilol	Tablet;Oral	Smithkline Beecham	Labeling Revision
Coreg Cr	carvedilol phosphate	Capsule, Extended Release;Oral	Sb Pharmco	Labeling Revision
Keytruda	pembrolizumab	Powder, For Injection Solution, Lyophilized Powder	Merck Sharp Dohme	Efficacy Supplement with Clinical Data to Support
Letairis	ambrisentan	Tablet;Oral	Gilead	Efficacy Supplement with Clinical Data to Support
Ritalin	methylphenidate hydrochloride	Tablet;Oral	Novartis	Manufacturing Change or Addition
Tobi Podhaler	tobramycin	Powder;Inhalation	Novartis	Labeling Revision

 

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— Tuesday, October 6, 2015 — Add Comment