CDER New February 20, 2018

February 16, 2018

• Public Meeting on Patient-Focused Drug Development for Opioid Use Disorder
• Office of Generic Drugs FY 2017 Regulatory Science Research Report
• Drug Approval Package: 
  • Keytruda (pembrolizumab) Injection
  • QVAR REDIHALER (beclomethasone dipropionate)
  • Syndros (dronabinol) Oral Solution
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• FDA Drug Shortages
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
  • Dorzolamide Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
  • Ketamine Injection (New - Currently in Shortage)    
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Orange Book (updated)
  • Orange Book Current Cumulative Supplement 2018 (PDF – 465KB) (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (ZIP - 690KB) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 90KB) (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)