CDER New October 3, 2016

What's New on the FDA Drugs Site

September 30. 2016

• CDER Drug Safety Priorities 2015-2016 (PDF - 2.28MB)
• Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) April - June 2016
• Drug Approval Packages:
  • DURLAZA  
  • Emend
  • Humalog  
  • Liletta  
  • Onivyde  
  • OPDIVO  
  • Vistogard  
• FDA Drug Shortages
  • Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
  • Technetium Tc99m Succimer Injection (DMSA) (New - Discontinuation)
  • Technetium Tc99m Succimer Injection (DMSA) (Updated - Currently in Shortage)
  • Tigecycline (Tygacil) Injection (Updated - Currently in Shortage)