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June 10, 2013 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Acetadote (acetylcysteine) Injection. The new labeling revises the product's indication and offers new dosing guidance for specific patient populations. Acetadote is free of EDTA or any other stabilization or chelating agents.
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 product's previous indication included the qualifying phrase, "administered intravenously within 8 to 10 hours," which was originally intended to impress the urgency for early treatment. This phrase has been removed due to potential confusion concerning efficacy when administration within that time period is not possible.
Furthermore, specific dosing guidance is now included for patients weighing over 100 kg. New language has also been added to alert health care providers that in certain clinical situations, therapy should be extended for some patients.
"We are committed to the further development of our products and worked with FDA and its Division of Medication Error Prevention and Analysis (DMEPA) to improve the package insert for Acetadote," said
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are pleased to provide clearer and more extensive dosing guidance to assist health care professionals when treating patients in a time-urgent and life-threatening situation. The label changes reflect our commitment to this patient population, which includes development of the EDTA-free Acetadote formulation."
Acetadote does not contain Ethylene diamine tetracetic acid (EDTA) or any other stabilization or chelating agents and is free of preservatives. The product's formulation was developed as part of a Phase IV commitment by
Cumberland in response to a request by the FDA to remove EDTA. The formulation also has a longer shelf life of 30 months.
Acetadote, which has been available in
the United States since
Cumberland's 2004 introduction of the product, 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 prescription and over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in
the United States.