Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.

Global pharma major Lupin Limited (Lupin) announced that it 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 USD 430 million in the U.S. (IQVIA MAT October 2023).