CDER New December 21, 2017

December 19, 2017

• Drug Approval Package:
  • PREVYMIS (letermovir)
  • Vyzulta (Latanoprostene Bunod) Ophthalmic Solution
• First Generic Drug Approval Update (updated)
• PDUFA Information Technology Plans (updated)
• AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial
• Drugs@FDA Data Files (updated)
• FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings 
• FDA Drug Shortages
  • Amoxapine Tablets (New - Currently in Shortage)
  • Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)
  • Fluvoxamine Tablets (New - Discontinuation)
• Manual of Policies and Procedures (MAPP)
  • 5232.1 Process for the Transfer of OAI CASES From OSIS TO OSI (PDF - 62KB)
  • 5232.2 Process for Handling OSIS Non-Concurrence with Decision to Downgrade EIR Classification at or after SAM (PDF - 75KB)
• Topical Antiseptic Drug Products (updated)