CDER New June

What's New on the FDA Drugs Site

June 16, 2017

• Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA updates on Pfizer drug shortages (updated)
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
• Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut^tm(Sodium Bicarbonate 4% Additive Solution), QUELICIN ^tm(Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance
• National Drug Code Directory
• Orange Book (updated)
  • A special note for users of the Orange Book Express mobile app
  • Orange Book Current Cumulative Supplement (PDF - 2.4MB)
  • May 2017: Additions and Deletions to the Drug Product List (PDF - 375KB)
  • Orange Book Data Files (compressed)  (ZIP - 638KB)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 86KB)
  • Orange Book Patent Listing Dispute List
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)