Zydus Cadila secures tentative approval from FDA for Brivaracetam Tablets

Cadila Healthcare (also known as Zydus Cadila) said that it has secured tentative approval from the US Food and Drug Administration (FDA) to market Brivaracetam Tablets in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

Brivaracetam is approved for the treatment of partial-onset of seizures (epilepsy).

Zydus Cadila will manufacture the epilepsy drug at the company’s formulation manufacturing facility at the SEZ, Ahmedabad.

The Indian pharma company now has 319 approvals and has so far submitted more than 400 ANDAs since the start of the filing process in FY 2003-04.

Last month, Zydus Cadila had been issued final approval from the FDA to market Fluphenazine Hydrochloride Tablets 1 mg, 2.5 mg, 5 mg, and 10 mg.