Lupin gets U.S. FDA nod smoking cessation treatment drug copy

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Lupin gets U.S. FDA nod smoking cessation treatment drug copy


Drugmaker Lupin has obtained U.S. Food and Drug Administration approval for its generic copy of smoking cessation treatment drugs Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V.

The product will likely be manufactured at its Pithampur facility in India, Lupin mentioned on Wednesday on the U.S. FDA approval for its abbreviated new drug utility for Varenicline Tablets, 0.5 mg and 1 mg.

Varenicline tablets, that are indicated to be used as an assist to smoking cessation treatment, had estimated annual gross sales of $430 million within the U.S., it mentioned citing IQVIA MAT October 2023 numbers. Lupin shares closed 1.20% decrease at ₹1,243.55 every on the BSE.



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