FDA Cancels Merck's Sugammadex NDA Advisory Panel Meeting

Source: Nasdaq

Mar 18, 2015


Merck received news that the FDA cancelled a previously scheduled meeting with the Anesthetic and Analgesic Drug Products Advisory Committee, intended to consider Merck's resubmitted new drug application (NDA) for sugammadex.

Merck is looking to get sugammadex approved in the U.S. for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

The FDA informed Merck that it intends to conduct additional site inspections related to a hypersensitivity study of the drug.

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