Zydus Cadila gets tentative US FDA approval for Brivaracetam tablets

Zydus Cadila has received tentative approval from the 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.