Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Febuxostat Tablets, 40 mg and 80 mg, to market a generic equivalent of Uloric Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals U.S.A., Inc.
The product will be manufactured at Lupin’s Pithampur facility in India.
Febuxostat Tablets, 40 mg and 80 mg, are indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Febuxostat Tablets (RLD Uloric) had estimated annual sales of USD 27 million in the U.S. (IQVIA MAT November 2023).
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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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.
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