Global pharma major Lupin Limited (Lupin) on Wednesday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent of Chantix® Tablets, 0.5 mg and 1 mg, of PF Prism C.V., the company announced through an exchange filing.
The product will be manufactured at Lupin’s Pithampur facility in India.
Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
Varenicline Tablets (RLD Chantix®) had estimated annual sales of USD 430 million in the U.S. (IQVIA MAT October 2023).
Lupin shares
The shares of Lupin on Wednesday at 10:19 am IST were trading at Rs 1,259.60, up by 0.11 percent.
About Lupin
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.
