CDER New September 6, 2017

What's New on the FDA Drugs Site

September 5, 2017

• Medication Guides Page (Updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Approval Package
  • Lynparza (olaparib)
• Drugs@FDA Data Files (updated)
• National Drug Code Directory (updated)
• PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)