Lupin gets US FDA nod to market its skin cream

Lupin has received final approval from the US health regulator to market its Desoximetasone cream, used for treatment of skin disease, in the US market.

Lupin said in a BSE filing that it "has received final approval for its Desoximetasone cream USP, 0.05 per cent and Desoximetasone cream USP, 0.25 per cent from the United States Food and Drug Administration (US FDA)".

The products to be marketed are generic versions of Taro’s Topicort Emollient cream, 0.05 per cent and Topicort cream, 0.25 per cent, it added.

As per IMS MAT September 2016 data Topicort LP emollient cream had US sales of $33 million while Topicort cream had US sales of $17 million, Lupin said.

"Both products are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses," it added.