Lupin receives US FDA approval for generic Chantix tablets

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (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.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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