CDER New January 4, 2017

What's New on the FDA Drugs Site

January 3, 2017

• Activities Report of the Generic Drug Program (FY 2017) (updated)
• Drug Approval Package: RAYALDEE (Calcifediol)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• FDA Drug Shortages 
  • Etomidate (Amidate) Injection (Discontinuation)
  • Tretinoin Cream (Tretin-X) (Discontinuation)
  • Naratriptan Hydrochloride Tablets (Discontinuation)
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Ketoprofen Capsules (Updated - Resolved)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Estradiol Valerate Injection, USP (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Tobramycin Injection (Updated - Currently in Shortage)
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Tobramycin Injection (Updated - Currently in Shortage)
• National Drug Code Directory
• Regulatory Policy Information (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)