CDER New: 9/9/2020

Drug Establishments Current Registration Site

What's New Related to Drugs

Updated Monday through Friday:

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File
• NDC Database Excluded Packages and Products
• Wholesale Distributor and Third-Party Logistics Providers Reporting

September 8, 2020

• Hematology/Oncology (Cancer) Approvals & Safety Notifications
  • FDA approves pralsetinib for lung cancer with RET gene fusions
  • FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer 
• Coronavirus Treatment Acceleration Program (CTAP) (update)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Hydralazine Hydrochloride Injection, USP (New - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 8, 2020