A tentative approval has been given to Zydus Cadila by the US health regulator to market epilepsy treatment drug called Brivaracetam tablets, informed the company on Monday.
Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Brivaracetam tablets, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, Cadila Healthcare said in a regulatory filing.
Zydus Cadila is a part of the Cadila group. Brivaracetam is used to treat partial-onset seizures (epilepsy). Zydus Cadila said the drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.
The group now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.