Lupin receives USFDA approval for generic Topicort Ointment, 0.05%

14 Dec 2016 Evaluate

Lupin has received final approval for its Desoximetasone Ointment USP, 0.05% from the United States Food & Drug Administration (USFDA) to market a generic version of Taro Pharms North’s Topicort Ointment, 0.05%. The product filing is from Lupin’s Pithampur (Indore) manufacturing facility. Topicort Ointment had US sales of $12.1 million, as per IMS MAT September 2016.

Lupin’s Desoximetasone Ointment USP, 0.05% is the AB rated generic equivalent of Taro Pharms North’s Topicort Ointment, 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Lupin had earlier on December 6, 2016, received final approval for its Desoximetasone Ointment USP, 0.25% from USFDA to market a generic version of Taro Pharmaceuticals, Inc.’s Topicort Ointment, 0.25% having US sales of $14.4 million, as per IMS MAT September 2016.


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