Lupin receives approval from USFDA for Varenicline Tablets

06 Dec 2023 Evaluate

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.


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