Cumberland gets FDA OK for Acetadote formulation

NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

Acetaminophen, which appears in numerous over-the-counter and prescription drugs for treating pain, cough and cold, is the leading cause of poisonings reported by hospital emergency rooms in the United States. The FDA recently adopted a rule requiring acetaminophen in prescription painkillers not to exceed 325 mg due to the risk of serious liver injury in patients who overdose on the drug.

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