FDA Sets Dates for New Diabetes, Opioid AdCom Meetings

The FDA has rescheduled its Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss Sanofi’s NDA for a fixed-dose combination of insulin glargine and lixisenatide for Type 2 diabetes. The agency moved the date from May 24 to May 25.

In addition, the agency set two new dates for the Anesthetic and Analgesic Drug Products Advisory Committee to review opioid NDAs. The committee will meet June 7 to review Teva’s hydrocodone NDA, and it will review Pfizer’s oxycodone NDA June 8.