Merck Says FDA Cancels Panel's Meeting To Review Sugammadex

(RTTNews) - Merck (MRK) announced that the U.S. Food and Drug Administration has cancelled advisory committee's meeting scheduled for March 18 to discuss the resubmission of the New Drug Application or NDA for sugammadex injection.

The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101).

Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015, saying the application is not yet ready for approval. Merck will continue to work with the FDA as it completes its review.

Sugammadex is an agent for reversal of neuromuscular blockade by the agentrocuronium in general anaesthesia.