USFDA okays Lupin Valbenazine Capsules to treat Dyskinesia
Mumbai: Pharma major, Lupin Limited, today announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg.
The product is a generic equivalent of Ingrezza Capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc.
Valbenazine is used for the treatment of tardive dyskinesia. Tardive dyskinesia is an uncontrollable movement of the tongue, face, or other body parts. Valbenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors.
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
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Lupin is a 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.
Lupin 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. It invested 8.7% of its revenue in research and development in FY22.
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