Incyte announces U.S. FDA has extended the supplemental new drug application review period for ruxolitinib cream (Opzelura) for the treatment of vitiligo

Incyte

14 March 2022 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new drug application for ruxolitinib cream (Opzelura) for the treatment of vitiligo. 

The Prescription Drug User Fee Act action date has been extended by three months to 18 July 2022.

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Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Dossier