CDER New November 22, 2017

November 21, 2017

• Drug Approval Package:
  • CARNEXIV (carbamazepine) Injection
  • ColPrep Kit (sodium sulfate, potassium sulfate and magnesium sulfate)

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: FASENRA
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefepime Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
• General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF - 519KB)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)