CDER New April 6, 2016

What's New on the FDA Drugs Site

April 5, 2016

• Drug Trials Snapshot: Cinqair
• Contents of a Complete Submission for the Evaluation of Proprietary Names Guidance for Industry (PDF - 146KB)
• FDA approves Inflectra (infliximab-dyyb), a biosimilar to Remicade
• FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin
• FDA Drug Shortages
  • Dexamethasone Sodium Phosphate Injection   (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection   (Updated - Currently in Shortage)
  • Meropenem for Injection, USP   (Updated - Resolved) 
  • Sufentanil Citrate (Sufenta) Injection   (Updated - Currently in Shortage)
  • Theophylline Extended Release Tablets and Capsules (Updated - Currently in Shortage)
• Purple Book: CDER List of Licensed Biological Products (PDF) (updated)