InnoPharma announced FDA approval of its Abbreviated New Drug Application (ANDA) for Acetylcysteine Injection, the generic version of Cumberland‘s Acetadote.

Acetadote Injection is administered intravenously within 8–10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen to prevent or minimize hepatic injury. It is thought to protect the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.

Acetylcysteine Injection will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials.  Acetylcysteine Injection is sterile and can be used for IV administration.

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