Lupin gets USFDA nod for partial-onset seizures drug Brivaracetam

Mumbai: Global pharma major, Lupin Limited, has recently announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

The product is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc.

This product will be manufactured at Lupin's Nagpur facility in India.

Brivaracetam Tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older.

Brivaracetam Tablets (RLD: Briviact Tablets) had estimated annual sales of USD 311 million in the U.S. (IQVIA MAT June 2021).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

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