Eligible for 180 days of shared exclusivity for Brivaracetam tablets.
Eligible for 180 days of shared exclusivity for Brivaracetam tablets.
Drugmaker Zydus Lifesciences has received United States Food and Drug Administration (USFDA) approval to market Brivaracetam tablets.
An antiepileptic drug, the approved product is a generic of Briviact from multinational pharma firm UCB. “US subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the USFDA to market Brivaracetam Tablets USP 10mg, 25mg, 50mg 75mg and 100mg,” Zydus said in a statement on October 6.
Because it was “one of the first ANDA applicants to have submitted a sufficiently complete ANDA with Article IV certification for Brivarcetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, it was a 180-day shared generic The drug is eligible for exclusivity.” ,
Zydus gets USFDA approval for generic drug
The company cited IQVIA numbers to say the approved drug had annual sales of $412 million in the US. 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 in Ahmedabad,” Zydus said.