Lupin gets USFDA approval for generic smoking cessation tablets

7 Dec 2023 , 02:44 PM

Lupin Ltd said on Wednesday that it has received permission from the US Food and Drug Administration to commercialize its generic Varenicline pills as an assistance to smoking cessation treatment. 

The US Food and Drug Administration (USFDA) approved an abbreviated new drug application for Varenicline tablets in strengths of 0.5 mg and 1 mg, according to Lupin in a regulatory filing.

These are the PF Prism CV generic counterparts of Chantix pills, 0.5 mg and 1 mg. According to the business, the product would be manufactured at Lupin’s Pithampur factory in India.

Varenicline tablets have expected annual sales of USD 430 million in the United States, according to the business, which cited IQVIA MAT October 2023 data.

At around 2.43 PM, Lupin was trading 0.60% higher at Rs 1,250.95 per piece, against the previous close of Rs 1,243.50 on NSE.

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