Today, Pfizer (PFE) announced that its supplemental new drug application -- sNDA -- has been accepted for review by the FDA. The review will be on the company's drug known as XELJANZ. The FDA will review whether or not it should approve the drug to treat patients with severely active Ulcerative Colitis. The Prescription Drug User Fee Act -- PDUFA -- has been established for March of 2018. That is when the FDA will decide if it should approve the drug for this patient population.
Phase 3 Data