FDA: Merck Post-Anesthesia Drug Approval Delayed Three Months

The FDA is requiring three more months to review Merck’s post-anesthesia drug, according to The Philadelphia Inquirer.

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The drug, sugammadex sodium, reverses the effects of anesthesia and helps patients regain consciousness after surgery. It was initially submitted for FDA approval in 2008 but rejected due to concerns about allergic reactions and excessive bleeding, according to the release.

Whitehouse Station, N.J.-based Merck submitted new data in January for the FDA to review. If approved, the injection would be the first in a new class of anesthesia drugs.

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