Zydus Lifesciences-led arm bags USFDA approval for ‘Brivaracetam Tablets'

6 Oct 2022 , 09:15 AM

The United States Food and Drug Administration (USFDA) has granted final permission to Zydus Lifesciences Limited’s (previously Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. to commercialise Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg with a paragraph IV certification.

Brivaracetam Tablets are therefore eligible for 180 days of shared generic medication exclusivity.

Brivaracetam is approved for the treatment of partial-onset seizures in children aged 4 and above.

The medicine would be produced at the group’s formulation manufacturing plant in Ahmedabad Special Economic Zone, India.

According to IQVIA statistics, Brivaracetam Tablets had annual sales of USD 412 million in the United States (IQVIA MAT August 2022).

At around 9.18 AM, Zydus Lifesciences was trading at Rs422.80 up by 0.67% from its previous closing of Rs420 on the BSE.

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