Zydus Lifesciences gets final approval from USFDA for Acetaminophen injection

29 Oct 2022 Evaluate

Zydus Lifesciences 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. 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 $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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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