CDER New March 26, 2015

What's New on the FDA Drugs Site

March 25, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA expands the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema
• FDA Drug Shortages
  • Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection   (Updated - Currently in Shortage)
  • Cefazolin Injection   (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection   (Updated - Currently in Shortage)
  • Haloperidol Lactate Injection   (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection   (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection   (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection   (Updated - Currently in Shortage)
  • Magnesium Sulfate Injection   (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Potassium Chloride Injection   (Updated - Currently in Shortage)
  • Reserpine Tablets   (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection   (Updated - Currently in Shortage)
  • Tobramycin Injection   (Updated - Currently in Shortage)
  • Vancomycin Hydrochloride for Injection, USP   (Updated - Currently in Shortage)
• National Drug Code Directory
• Paragraph IV Patent Certifications  (updated)