Zydus Lifesciences US arm bags USFDA nod for Brivaracetam Tablets to treat partial-onset seizures
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.;
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Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the United States Food and Drug Administration (USFDA) to market Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. (USRLD: Briviact).
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.
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