Lupin announced that it has received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) Brivaracetam Tablets.
Lupin announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, to market a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc.
Brivaracetam Tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older. This product will be manufactured at Lupin's Nagpur facility in India.
Brivaracetam Tablets (RLD: Briviact Tablets) had estimated annual sales of $311 million in the U.S. (IQVIA MAT June 2021).
The announcement was made after market hours yesterday, 16 August 2021. Shares of Lupin fell 0.95% to settle at Rs 967.30 yesterday.
Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs.
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