Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 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 $430 million in the U.S. (IQVIA MAT October 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
