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news.The US Food and Drug Administration (FDA)has approved Cumberland Pharmaceuticals' new formulation of Acetadote (acetylcysteine) injection, as a treatment for acetaminophen poisoning.
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Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury.
Cumberland Pharma said following this approval it will stop manufacturing of the previous formulation of the drug and is now planning to launch the drug in US.
Cumberland Pharma CEO A J Kazimi said that they are committed to further developing our products, whether to expand into new patient populations or to improve upon an existing formulation, and worked with the FDA to develop this new formulation of Acetadote.
"We look forward to introducing this product to the hospital community and the growing number of patients who will benefit from it," Kazimi said.