Cumberland Pharmaceuticals has received the US Food and Drug Administration’s (FDA’s) approval for updated labeling of Acetadote (acetylcysteine) Injection, which is free from Ethylene diamine tetracetic acid (EDTA) or any other stabilization or chelating agents.
Stating improved product's indication, the new label provides dosing guidelines for different categories of patients, including those weighing over 100kg.
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."
Cumberland Pharmaceuticals CEO A J Kazimi said that the new labeling has more extensive dosing guidance to enable health care professionals when treating patients in a time-urgent and life-threatening situation.
Acetadote, which has an extended shelf life of 30 months, is used to prevent or reduce 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.
Cumberland Pharma specializes in the acquisition, development and commercialization of branded prescription products.
