The US Food and Drug Administration (FDA) has approved InnoPharma's abbreviated new drug application (ANDA) for acetylcysteine injection.
The acetylcysteine injection, which is a generic equivalent of Cumberland Pharmaceuticals' Acetadote injection, is indicated as an antidote to prevent or lessen hepatic injury that occurs following the ingestion of a potentially hepatotoxic quantity of acetaminophen.
Sterile acetylcysteine injection can be used for I.V. administration and will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials.
To expand the commercialization of the product in the US, InnoPharma has an agreement with Fresenius Kabi for its APP division.
InnoPharma has 180 days of generic drug exclusivity from FDA for its ANDA.
