Category: Approval/Launch Region: Asia · India Company: Lupin Ltd

Lupin gets USFDA nod to market generic product

Lupin gets USFDA nod to market generic product
The company has received approval from the United States Food and Drug Administration (FDA) to market the generic version of Bausch Health Americas' Jublia topical solution, the Mumbai-based drug maker said in a regulatory filing. Drug major Lupin on Thursday said it has received approval from the US health regulator to market Efinaconazole topical solution, used to treat fungal toenail infections, in the American market. The company has received approval from the United States Food and Drug Administration (FDA) to market the generic version of Bausch Health Americas' Jublia topical solution, the Mumbai-based drug maker said in a regulatory filing. The product will be manufactured at the company's facility in Pithampur, it added. estimated annual sales of USD 274 million in the US.

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