Incyte Announces U.S. FDA Has Extended the Supplemental New Drug Application Review Period for Ruxolitinib Cream (Opzelura™) for the Treatment of Vitiligo

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Mar 14, 2022

Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura™)for the treatment of vitiligo. The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18, 2022.