Zydus gets final approval for Acetylcysteine Injection from USFDA

Mumbai: Pharma Major, Zydus Cadila has received the final approval from the USFDA to market Acetylcysteine Injection (US RLD - Acetadote Injection), 6 g/30 mL (200 mg/mL).

It is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen, the company said in a filing with BSE.

It will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad.

In line with this, the group now has 211 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.