Merck says FDA need additional time to asses clinical trial site

theflyonthewall.com

Merck confirmed that the U.S. FDA has cancelled Thursday’s discussion of sugammadex at the Anesthetic and Analgesic Drug Products Advisory Committee. Sugammadex sodium injection is Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. The FDA advised Merck that the agency needs additional time to assess the results of the FDA’s recently completed inspection of a clinical trial site. The site was one of four sites that conducted the hypersensitivity study previously requested by the agency. Merck is engaged in discussions with the FDA to identify the steps necessary to enable the agency to complete its review.

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