Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market acetylcysteine injection, 6 g/30 mL (200 mg/mL) single-dose vials. The product, which is generic version of Cumberland Pharmaceuticals’ Acetadote injection, is expected to be launched in Q1 FY16-17.
Acetylcysteine injection is an antidote for acetaminophen (non-aspirin pain reliever or analgesic) overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. The approved product has an estimated market size of $ 28 million for the twelve months ending December 2015, according to IMS.
