Lupin Secures USFDA Nod For Generic Chantix Tablets to Aid Smoking Cessation
According to media reports, Lupin announced a significant milestone on Wednesday as the United States Food and Drug Administration (USFDA) approved its Abbreviated New Drug Application (ANDA) related to Varenicline tablets, 0.5 mg, and 1 mg. These tablets will serve as a generic equivalent to Chantix Tablets, 0.5 mg, and 1 mg, originally developed by PF Prism C.V., the media reports informed.
The approved product will be produced at Lupin's unit in Pithampur, India. Varenicline Tablets, with dosages of 0.5 mg and 1 mg, are specifically designed to aid individuals in their smoking cessation treatment.
The market for Varenicline tablets, recognised as the Reference Listed Drug (RLD Chantix), boasts an estimated annual sales figure of USD 430 million in the United States. Lupin's successful approval marks a significant step in providing an affordable and accessible generic alternative to support smoking cessation efforts.
