Zydus receives USFDA approval for Brivaracetam Tablets

11 Oct 2022 , 01:34 AM

Zydus Lifesciences US 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 Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older The drug will be manufactured at the groups formulation manufacturing facility at Ahmedabad SEZ India Brivaracetam Tablets USP 10 mg 25 mg 50 mg 75 mg and 100 mg had annual sales of USD 412 mn in the United States according to IQVIA data IQVIA MAT August 2022