Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Varenicline tablets indicated for use as an aid to smoking cessation treatment.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Varenicline tablets of strengths 0.5 mg and 1 mg, Lupin said in a regulatory filing.
These are the generic equivalents of Chantix tablets, 0.5 mg and 1 mg, of PF Prism CV.
"The product will be manufactured at Lupin's Pithampur facility in India," the company said.
Varenicline tablets, 0.5 mg and 1 mg, are indicated for use as an aid to smoking cessation treatment, it added.
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Varenicline tablets had estimated annual sales of USD 430 million in the US, the company said, citing IQVIA MAT October 2023 data.
