CDER New April 28, 2016

What's New on the FDA Drugs Site

April 27, 2016

• Drugs@FDA Data Files (updated)
• FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure
• Medication Guide page Updated: Xtampza ER
• FDA Drug Shortages
  • Cefazolin Injection   (Updated - Currently in Shortage)
• Fresenius Kabi Issues Voluntary Nationwide Recall of Sensorcaine-MPF (bupivacaine HCl) Injection, USP due to the Presence of Particulate Matter Characterized as Glass
• GDUFA Reauthorization Stakeholder Meetings (updated)
• Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)