Zydus receives final approval from USFDA for Acetaminophen injection
Drug Approval

Zydus receives final approval from USFDA for Acetaminophen injection

Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data

  • By IPP Bureau | October 30, 2022

Zydus Lifesciences Limited (formerly known as Cadila Healthcare 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.

Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data (IQVIA MAT Aug 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.

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