Mumbai, Baltimore, August 16, 2021: Global pharma major Lupin Limited (Lupin) today 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. 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).
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.
The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.
Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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Head – Corporate Communications
Briviact® is a registered trademark of UCB Biopharma SPRL.