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FDA approves Merck's Bridion

December 15, 2015 8:00 AM UTC

FDA approved Bridion sugammadex from Merck & Co. Inc. (NYSE:MRK) to reverse the effects of neuromuscular blockade induced by muscle relaxants rocuronium or vecuronium. Merck spokesperson Pamela Eisele said the company plans to launch the cyclodextrin derivative in January, at which time it will disclose Bridion's price.

FDA initially rejected Bridion in July 2008 and requested additional studies on anaphylaxis and hypersensitivity reactions. The agency rejected the drug again in September 2013 and April 2015 due to concerns over hypersensitivity data. ...