CDER New January 2, 2018

December 29, 2017

• Drug Approval Package:
  • Fasenra (benralizumab) 30 mg/mL Injection
  • Ilaris (canakinumab) Injection
  • HEMLIBRA (emicizumab-kxwh) Injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• Labeling for Combined Hormonal Contraceptives Draft Guidance for Industry (PDF - 437KB)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)