Zydus Pharma (USA) has received final approval from the US Food and Drug Administration (FDA) to market Brivaracetam tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, a company statement informed.
Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brivaracetam tablets USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. It is, therefore, eligible for 180 days of shared generic drug exclusivity for Brivaracetam tablets USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, it said.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients four years of age and
older. The drug will be manufactured at the group’s formulation-manufacturing facility at Ahmedabad SEZ, India.
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