CDER New July 16, 2018

July 13, 2018

• FDA approves TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox
• Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry (PDF - 57KB) 
• ICH Harmonised Guideline: Q3D(R1) Elemental Impurities (PDF - 177KB) 
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• Orange Book
  • Orange Book Current Cumulative Supplement 2018 (PDF – 975KB) (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (ZIP - 704KB) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 91KB) (updated)
  • Orange Book Patent Listing Dispute List (updated)
  • Appendix A: Product Name Index (PDF - 168KB) (updated)
  • Appendix B: Product Name Sorted by Applicant (PDF - 410KB) (updated)
  • Appendix C: Uniform Terms (PDF - 25KB) (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)