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This Article is From Dec 14, 2016

Lupin Gets US Regulator's Nod To Market Generic Skin Ointment

Lupin Gets US Regulator's Nod To Market Generic Skin Ointment
Lupin said the product filing is from its Pithampur manufacturing facility.

New Delhi: Pharmaceuticals firm Lupin has received approval from the US Food and Drug Administration (FDA) to market its Desoximetasone ointment, used for providing relief from inflammation and itching in a skin disease.

The company has received final approval to market its Desoximetasone ointment USP, 0.05 per cent from the US health regulator, Lupin said in a filing to the BSE.

The product filing is from the company's Pithampur manufacturing facility, it added.

The Mumbai-based company's product is the generic version of Taro Pharms North's Topicort ointment in the same strength.

As per IMS, MAT September 2016 sales data, Topicort had US sales of $12.1 million, Lupin said.

The ointment is "indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses," it added.

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