CDER New September 21, 2015

What's New on the FDA Drugs Site

September 18, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
• FDA Drug Shortages
  • Hexabrix (New - Discontinuation)
  • Iodopen (New - Discontinuation)
  • Metoprolol Injection (New - Currently in Shortage)
  • Nebivolol (BYSTOLIC) Tablets   (Updated - Currently in Shortage) 
  • Sodium Acetate Injection, USP (New - Discontinuation)
• National Drug Code Directory
• Orange Book (updated)
  • August 2015: Additions and Deletions to the Drug Product List (PDF - 128KB)
  • Orange Book Current Cumulative Supplement (PDF - 1014KB)
  • Orange Book Data Files (compressed) (ZIP - 607KB) 
    
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
• Product-Specific Recommendations for Generic Drug Development (updated)
• Public Meeting on Patient-Focused Drug Development for Huntington’s and Parkinson’s Diseases(updated)