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Regulators Approve New Acetadote Formulation

By Drug Discovery Trends Editor | January 14, 2011

NASHVILLE, Tenn. (AP) – Cumberland Pharmaceuticals Inc. said 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.

Date: January 13, 2011
Source: Associated Press

 


Filed Under: Drug Discovery

 

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