Zydus Lifesciences gets USFDA’s final nod for Oxcarbazepine Tablets

04 Jul 2023 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg (USRLD: Trileptal Tablets, 150 mg, 300 mg, and 600 mg).

Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). The product will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh (India). Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg had annual sales of $105 million in the United States (IQVIA MAT May 2023).

The group now has 374 approvals and has so far filed over 442 ANDAs as of March 31, 2023 since the commencement of the filing process in FY 2003-04. 

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

Zydus Lifesciences Share Price

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