News
Incyte announces the FDA has extended the sNDA review period for ruxolitinib in chronic graft-versus-host disease (GVHD),
Incyte announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).
The new Prescription Drug User Fee Act (PDUFA) target action date is September 22, 2021. The FDA extended the PDUFA action date to allow time to review additional data submitted by Incyte in response to the FDA’s information request. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.
Condition: Graft-v-Host Disease (GvHD)
Type: drug
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