Lupin gets USFDA approval for generic smoking cessation treatment tablets

Lupin announced on Wednesday that it has secured approval from the US Food and Drug Administration (USFDA) to market its generic Varenicline tablets. These tablets are designed as an aid for smoking cessation treatment.

The approval covers Varenicline tablets in strengths of 0.5 mg and 1 mg, serving as generic alternatives to Chantix tablets in the same strengths manufactured by PF Prism CV, as per Lupin's regulatory filing.

Lupin specified that these tablets will be manufactured at its Pithampur facility, located in India. The company highlighted that Varenicline tablets, available in 0.5 mg and 1 mg strengths, are specifically intended for use as a tool in smoking cessation treatment.

Additionally, Lupin noted that according to IQVIA MAT October 2023 data, the Varenicline tablets had an estimated annual sales figure of $430 million in the US market.

(With PTI Inputs)