FDA panel to discuss Pfizer's Xeljanz in UC
FDA's Gastrointestinal Drugs Advisory Committee will meet on March 8 to discuss an sNDA from Pfizer Inc. (NYSE:PFE) for Xeljanz tofacitinib tablets to treat adults with moderate to severe active ulcerative colitis.
In December, FDA delayed the PDUFA date three months to June 2018 in order to review newly submitted information. The oral pan-Janus kinase (JAK) inhibitor is approved in the U.S. to treat rheumatoid arthritis and psoriatic arthritis.
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