FDA Revokes Approval For 7 Acetaminophen Painkillers

Law360, New York (July 16, 2014, 7:05 PM EDT) -- The U.S. Food and Drug Administration on Wednesday revoked approval for seven narcotic painkillers that contain acetaminophen, including versions of AbbVie Inc.’s Vicodin, in the agency’s latest action in response to concerns about the ingredient’s potential to cause severe liver damage.

The move comes more than three years after regulators announced plans to cap the amount of acetaminophen in prescription drugs at 325 milligrams per dose. Three versions of AbbVie’s Vicodin, which combines acetaminophen and hydrocodone, were affected by the action.

Two similar products sold by Actavis Inc. and Nesher Pharmaceuticals USA LLC also had their approvals withdrawn. And products made...

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