Breaking News, Trials & Filings

Merck Drug Receives CRL

Sugammadex continues troubled development path

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Merck has received a Complete Response Letter from the FDA for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. The FDA’s letter raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the very near fu...

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