CDER New May 11, 2015

What's New on the FDA Drugs Site

May 8, 2015

• Drug Trials Snapshots
  • CHOLBAM: For treatment of bile acid synthesis disorders due to single enzyme defects 
  • CHOLBAM: For treatment of peroxisomal disorders, including Zellweger spectrum disorders 
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Dextrose 5% Injection Bags   (Updated - Currently in Shortage)
  • Dextrose Injection USP, 70%   (Updated - Currently in Shortage)
  • Epinephrine Injection   (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection   (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection   (Updated - Currently in Shortage)
  • Magnesium Sulfate Injection   (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric)   (Updated - Currently in Shortage)
  • Nalbuphine Hydrochloride (Nubain) Injection   (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Potassium Chloride Injection   (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags   (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection   (Updated - Currently in Shortage)
• National Drug Code Directory
• Pediatric Exclusivity Granted  (updated)