04:49 PM EDT, 06/20/2025 (MT Newswires) -- Incyte ( INCY ) said Friday the US Food and Drug Administration has extended the review period for the supplemental new drug application for ruxolitinib cream to treat children with mild to moderate atopic dermatitis.

The prescription drug user fee act action date has been extended to Sept. 19, Incyte ( INCY ) said.

The regulator extended the action date to have more time to review additional chemistry, manufacturing and controls data on the 0.75% strength submitted by Incyte ( INCY ) in response to a recent FDA information request, the company said.