FDA advisory committee recommends sugammadex to reverse rocuronium or vecuronium during surgery- Merck
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously in favour of approving sugammadex (known as Bridion in the EU) for the reversal of neuromuscular blockade induced by the agents rocuronium or vecuronium during surgery. The FDA will review the recommendation on 19th December. If approved, Bridion will be the first in a new class of selective relaxant binding agents to enter the US market.
Comment: The drug was rejected three times by the FDA as regulators were concerned by the risk of allergic reactions, such as hypersensitivity or anaphylaxis, and a risk of cardiac dysrhythmias. Bridion is marketed in more than 70 countries.
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