Zydus Lifesciences gets FDA final approval for Ofirmev generic

Zydus Lifesciences Limited (formerly Cadila Healthcare) said that it has secured final approval from the US Food and Drug Administration (FDA) for Acetaminophen Injection, 1,000 mg/100 mL (10 mg/mL) single-dose vials.

The product is the generic of Ofirmev. It is approved for easing mild to moderate pain and bringing down fever. Ofirmev also has the approval to be used in combination with opioid (narcotic) drugs for relieving pain that is at moderate to severe levels.

Zydus Lifesciences will manufacture Acetaminophen Injection at its injectable manufacturing plant in Jarod, near Vadodara.

Zydus Lifesciences gets FDA final approval for Ofirmev generic — Acetaminophen Injection. Photo courtesy of Zydus Cadila.

According to IQVIA MAT Aug 2022, Acetaminophen injection had sales of $72 million in the US.

Zydus Lifesciences said that it currently has 330 approvals and to date filed more than 428 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.