What's New Related to Drugs

September 13, 2019

• FDA Drug Safety Communication: FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer
• KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: Rozlytrek
• National Drug Code Directory (updated)
• Orange Book (updated)
  • Orange Book Current Cumulative Supplement
  • Additions/Deletions for Prescription and OTC Drug Product Lists
  • Orange Book Data Files (compressed)
  • Reference Listed Drugs by ANDA Reference Standard List
  • Orange Book Patent Listing Dispute List
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (updated)
• Drug Presentations (updated)