CDER New January 23, 2018

January 19, 2018

• Extension of Shelf  Life Provided by Baxter Healthcare Corporation to Assist with IV Solution Shortages 
• Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2018 (PDF - 48KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• FDA Drug Shortages
  • Aminocaproic Acid Injection, USP (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection Bags (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Diazepam Injection, USP (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole (Protonix) Powder for Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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