CDER New July 11, 2016

What's New on the FDA Drugs Site

July 8, 2016

• Drug Approval Packages:
  • Inflectra
  • Ocaliva
  • Zinbryta 
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA approves a dedicated syringe to be used with Humulin R U-500 insulin
• FDA approves Differin Gel 0.1% (adapalene) for over-the-counter use to treat acne
• FDA Drug Shortages
  • Penicillin G Benzathine (Bicillin L-A) Injection (Updated - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (PDF - 94KB)