USFDA approves Lupin’s Varenicline tablets

Indian multinational pharmaceutical company Lupin Limited (Lupin) on Wednesday (December 6, 2023) announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Varenicline Tablets.

The nod was given to 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., Lupin 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).

(The article is published under a mutual content partnership arrangement between The Free Press Journal and Connected to India)