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Cumberland Gets Approval of New Acetadote Formula

From Associated Press (January 13, 2011)

NASHVILLE, Tenn. -- Cumberland Pharmaceuticals Inc. said Thursday the Food and Drug Administration approved a new formulation of its Acetadote injection used to treat acetaminophen poisoning.

The company said the new formulation will not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives. It will replace the currently marketed product.

The drug is used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products.

Cumberland’s announcement comes on the same day the FDA said it will cap the amount of acetaminophen in various drugs at 325 milligrams per capsule because of the potential for toxic overdoses when taken in combinations.

Shares of Cumberland fell 3 cents to close at $5.67.

Posted: January 2011