CDER New January 16, 2018

January 12, 2018

• Drug Approval Package:
  • CABOMETYX (cabozantinib) Tablets
  • INTRAROSA (prasterone) Vaginal Inserts
  • SMOFLIPID (Lipid Injectable Emulsion)
  • STELARA (ustekinumab) Injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• FY2017 Regulatory Science Report: Locally-Acting Orally Inhaled and Nasal Drug Products
• FDA approves Lynparza (olaparib tablets), the first treatment for breast cancer with a certain inherited genetic mutation
• National Drug Code Directory (updated)
• Orange Book (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 88KB) (updated)
  • Orange Book Data Files (compressed) (ZIP - 669KB) (updated)
  • Orange Book Current Cumulative Supplement 2017 (PDF - 1.8MB) (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (December 2017 added)
  • Orange Book Patent Listing Dispute List (updated)
  • Appendix A: Product Name Index (PDF - 167KB) (updated)
  • Appendix B: Product Name Sorted by Applicant (PDF - 402KB) (updated)
  • Appendix C: Uniform Terms (PDF - 24KB) (updated)
• Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)