AbbVie Inc., et al.; Proposal To Withdraw Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen; Opportunity for a Hearing

摘要

The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of abbreviated new drug applications (ANDAs) from multiple sponsors for prescription pain medications containing more than 325 milligrams (mg) of acetaminophen. The basis for this proposal is that the Agency has determined that fixed-combination prescription drugs containing more than 325 mg of acetaminophen per dosage unit (tablet or capsule) do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury.