Merck & Co. April 28 announced that it has received a complete response letter (CRL) for its resubmitted new drug application for sugammadex injection.
Merck, which is based in Whitehouse Station, N.J., 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.
The company said it is evaluating the information provided in the letter.
In March, Merck said it expected to receive the CRL because the FDA cancelled an advisory committee meeting on sugammadex scheduled for March 18 13 PLIR 403, 3/20/15
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