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FDA Needs More Time To Review Sugammadex Inspection Report, Cancels Advisory Committee

 
• By Derrick Gingery

Merck’s anesthesia reversal agent, which was deemed “not approvable” in 2008, faces another setback as FDA cancels its July 18 advisory committee meeting to allow more time to review clinical trial site inspection data.

It appears a last-minute data issue may have complicated the review of Merck & Co. Inc.’s anesthesia injection sugammadex.

FDA announced July 16, two days before a scheduled Anesthetic and Analgesic Drug Products Advisory Committee meeting to consider the...

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