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Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings Pfizer Inc. announced today that the U.S. Food and Drug Administration has notified the company that it will not meet the Prescription Drug User Fee Act goal dates for the New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis and the supplemental New Drug Application for XELJANZXELJANZ XR for the treatment of adults with active ankylosing … Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has notified the company that it will not meet the Prescription Drug User Fee Act (PDUFA) goal dates for the New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis and the supplemental New Drug Application for XELJANZ/XELJANZ XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pf

Michael corboBryan dunnSteve danehyExchange commissionPfizer incDrug administrationPfizer global product developmentPrescription drug user fee actNew drug applicationChief development officerPfizer global productBarr virus associatedNon steroidal anti inflammatory drugsEnzyme elevationsImportant safety informationPrescribing information