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Lupin receives USFDA nod for generic Topicort LP Emollient Cream, Topicort cream

11 Jan 2017 Evaluate

Lupin has received final approval for its Desoximetasone Cream USP, 0.05% and Desoximetasone Cream USP, 0.25% from the United States Food and Drug Administration (USFDA) to market a generic equivalent of Taro Pharmaceuticals North America, Inc’s Topicort LP Emollient Cream, 0.05% and Taro Pharmaceuticals, Inc’s (collectively Taro) Topicort Cream, 0.25%.

Desoximetasone Cream USP, 0.05% and Desoximetasone Cream USP, 0.25% are the AB rated generic equivalent of Taro’s Topicort LP Emollient Cream, 0.05% and Topicort Cream, 0.25%. Both products are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topicort LP Emollient Cream had US sales of $33 million while Topicort Cream had US sales of $17 million, as per IMS MAT September 2016.

Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.


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