Cumberland sNDA for Acetadote approved by FDA

The FDA approved a supplemental NDA for Acetadote, an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion, approving changes to the Dosage and Administration section of the label, according to prescribing information posted to the agency’s website.