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Lupin gets US FDA tentative approval for valbenazine capsules

Our Bureau, Mumbai
Monday, March 27, 2023, 15:15 Hrs  [IST]

Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), valbenazine capsules, 40 mg, 60 mg, and 80 mg, to market a generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc.
Valbenazine capsules (Ingrezza) had estimated annual sales of USD 1,235 million in the US (IQVIA MAT December 2022).
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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.


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