Lupin gets US FDA approval for Varenicline Tablets
They are indicated for use as an aid to smoking cessation treatment
Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent of Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V.
The product will be manufactured at Lupin’s Pithampur facility in India. Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
Varenicline Tablets (RLD Chantix) had estimated annual sales of $430 million in the US (IQVIA MAT October 2023).
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