Cumberland reports FDA approval for updated acetadote labeling

Cumberland announced that the FDA has approved updated labeling for Acetadote 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.

View Comments (0)