CDER New December 18, 2014

What's New on the FDA Drugs Site

December 17, 2014

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Xtoro (finafloxacin otic suspension) to treat swimmer’s ear
• FDA Drug Shortages: New and Updated
  • Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection   (Currently in Shortage)
  • Calcium Gluconate Injection   (Currently in Shortage)
  • Cefazolin Injection   (Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection   (Currently in Shortage)
  • Haloperidol Lactate Injection   (Currently in Shortage)
  • Heparin Sodium Injection   (Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection   (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection   (Currently in Shortage)
  • Potassium Chloride Injection   (Currently in Shortage)
  • Quazepam (Doral) Tablets (New - Discontinuation)
  • Sodium Chloride 0.9% Injection Bags   (Currently in Shortage)
  • Tobramycin Solution for Injection   (Currently in Shortage)
  • Trace Elements   (Currently in Shortage)
• Guidance for Industry:
  • Providing Regulatory Submissions In Electronic Format — Standardized Study Data (PDF - 124KB)
  • Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF - 81KB)
• Are you ready for the Drug Supply Chain Security Act?
• National Drug Code Directory
• Paragraph IV Patent Certifications (updated)

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New and Generic Drug Approvals

December 16, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Chg Scrub	chlorhexidine gluconate	Solution;Topical	Ecolab	Manufacturing Change or Addition
Cida-Stat	chlorhexidine gluconate	Solution;Topical	Ecolab	Manufacturing Change or Addition
Diastat	diazepam	Gel;Rectal	Valeant Pharms North	Labeling Revision
Diastat Acudial	diazepam	Gel;Rectal	Valeant Pharms North	Labeling Revision
Diclegis	doxylamine succinate; pyridoxine hydrochloride	Tablet, Delayed Release;Oral	Duchesnay	Labeling Revision
Primaxin	cilastatin sodium; imipenem	Powder;Intravenous	Merck	Labeling Revision
Somatuline Depot	lanreotide acetate	Injectable;Subcutaneous	Ipsen Pharma	Supplement
Wellbutrin	bupropion hydrochloride	Tablet;Oral	Glaxosmithkline	Labeling Revision
Wellbutrin Sr	bupropion hydrochloride	Tablet, Extended Release;Oral	Glaxosmithkline	Labeling Revision

 

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