On Monday, Zydus Cadila said that they received tentative approval from the US health regulator to market epilepsy treatment drug Brivaracetam tablets.
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.
Now the group has approvals of 319 and has so far field over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.