CDER New December 2, 2016

What's New on the FDA Drugs Site

December 1, 2016

• FDA Drug Shortages
  • Alendronate Sodium Tablets USP (New - Discontinuation) 
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
• Medication Guides Page (updated)
• Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 92KB)