Zydus receives USFDA final approval for Acetaminophen injection

31 Oct 2022 , 09:16 AM

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Acetaminophen Injection, 1,000 mg/100 mL (10 mg/mL) single-dose vials (USRLD: Ofirmev).

Acetaminophen injection is indicated to relieve mild to moderate pain and to reduce fever. It is also used in combination with opioid (narcotic) medications to relieve moderate to severe pain. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India.

Acetaminophen injection had annual sales of USD 72 million in the United States according to IQVIA data (IQVIA MAT August 2022).

The group now has 330 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

On Monday early morning trade, Zydus Lifesciences Ltd is currently trading at Rs434.05 per share up by Rs4.55 or 1.06% from its previous closing of Rs429.50 per share on the BSE.

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