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