USFDA approves Lupin Valbenazine Capsules
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Valbenazine Capsules, 40 mg and 80 mg, to market a generic equivalent of Ingrezza Capsules, 40 mg and 80 mg, of Neurocrine Biosciences, Inc.
"Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity," the Company stated.
The product will be manufactured at Lupin’s Nagpur facility in India.
Valbenazine Capsules, 40 mg and 80 mg (RLD Ingrezza) had estimated annual sales of USD 1621 million in the U.S. (IQVIA MAT February 2024).
Medical Dialogues team had earlier reported the Company had received approval from the US health regulator to market a generic medication to treat bacterial infections, in America.
Read also: Lupin gets USFDA nod to market a generic drug to treat bacterial infections
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.
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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. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin bags USFDA nod for Eslicarbazepine Acetate Tablets for partial-onset seizures
