Lupin has received approval from the United States Food and Drug Administration (US 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 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 US (IQVIA MAT October 2023).