FDA reschedules review date for sugammadex- Merck Inc.

The FDA has rescheduled a meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee for 6 November 2015 to review sugammadex injection, an injectable agent to reverse neuromuscular blockade induced by rocuronium or vecuronium .This is the fourth time sugammadex has come for review and follows submission by Merck Inc. of its response to a FDA Complete Response Letter. The FDA has set 19 December as the new Prescription Drug User Fee Act action date.

Comment: sugammadex currently is marketed in about 60 countries outside the US under the brand name Bridion. Anesethiologists use muscle relaxants to improve surgical conditions and facilitate inturbation and mechanical ventilation. After surgery reversal agents enable patients to regain normal muscle function sooner and breath on their own. Current reversal agent are slow and have side effects. Sugammadex is effective within 3 minutes and is now indicated for immediate reversal of commonly used steroid muscle relaxants such as rocuronium and vecuronium.