Lupin gets US FDA 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

Lupin recently 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 US 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.

As per QVIA MAT December 2021 data, Efinaconazole topical solution had estimated annual sales of $274 million in the US.

Bausch Health AmericasEfinaconazolegeneric productLupinUS FDA
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