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Cumberland Pharmaceuticals, Inc. (CPIX) Gets FDA Approval For Updated Acetadote Labeling

|Includes: Cumberland Pharmaceuticals Inc. (CPIX)

Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on the acquisition, development, and commercialization of branded prescription products. The company's primary target markets include hospital acute care and gastroenterology. Its product portfolio includes Kristalose (prescription laxative), Caldolor injection (treatment for pain and fever), and Acetadote injection for treatment of acetaminophen poisoning.

The company announced today that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Acetadote injection. Acetadote is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many pain killers, both prescription and over-the-counter. Acetaminophen remains one of the leading causes of poisoning in the U.S.

The new labeling revises the indication for Acetadote and offers new dosing guidance for specific populations. The new indication states, "Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen." The new wording for Acetadote eliminated the confusion about concerning efficacy when a dose was not administered within 8 to 10 hours. Specific dosing is now included for patients weighing over 100 kilograms.

Acetadote does not contain ethylene diamine tetracetic acid (OTCPK:EDTA) or any other stabilization or chelating agents and is free of preservatives. Cumberland's current updated formulation has a longer shelf life of 30 months. For additional information about Acetadote, go to For a look at Cumberland Pharmaceuticals' entire product line, please visit

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