CDER New January 13, 2017

What's New on the FDA Drugs Site

January 12, 2017

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• FDA Drug Shortages
  • Penicillin G Benzathine (Bicillin L-A) Injection (Updated - Currently in Shortage)
  • Penicillin G Benzathine and Penicillin G Procaine (Bicillin C-R) Injection (Updated - Currently in Shortage)
  • Penicillin G Procaine Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Tigecycline (Tygacil) Injection (Updated - Currently in Shortage)
• Guidance for Industry 180-Day Exclusivity: Questions and Answers (PDF - 240KB)
• Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics
  License Application Guidance for Industry (PDF - 969KB)
• Nonproprietary Naming of Biological Products Guidance for Industry (PDF - 115KB)
• Multiple Endpoints in Clinical Trials (PDF - 687KB)
• National Drug Code Directory
• Orange Book
  • Appendix A: Product Name Index (PDF - 149KB)
  • Appendix B: Product Name Sorted by Applicant (PDF - 335KB)
  • Appendix C: Uniform Terms (PDF - 50KB)
  • December 2016: Additions and Deletions to the Drug Product List (PDF - 152KB)
  • Orange Book Current Cumulative Supplement (PDF - 1.6MB)
  • Orange Book Data Files (compressed) (ZIP - 636KB)
• Paragraph IV Patent Certifications (updated)
• Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Guidance for Industry (PDF - 646KB)