Zydus Cadila receives USFDA’s tentative approval for Brivaracetam Tablets

14 Jun 2021 Evaluate

Zydus Cadila has received tentative approval from the United States Food and Drug Administration (USFDA) to market Brivaracetam Tablets, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg (US RLD: Briviact Tablets). Brivaracetam is used to treat partial-onset of seizures (epilepsy).

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 319 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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