Merck & Co. March 13 said it expects to receive a complete response letter (CRL) for its resubmitted new drug application for sugammadex injection.
Merck is seeking approval of the drug for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. Neuromuscular blockade is used in anesthesiology to induce muscle relaxation during surgery.
In a press release, the company said it expects to receive the CRL by April 22, which is the Prescription Drug User Fee Act (PDUFA) action date for the NDA.
Advisory Panel Canceled.
Merck, which is based in Whitehouse Station, N.J., also said the FDA canceled ...
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