Additional review time requested for ulcerative colitis drug

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Pfizer Inc. said Tuesday the Food and Drug Administration has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ®(tofacitinib).

The oral medication is for adults with moderately to severely active ulcerative colitis. It's estimated that between 10% and 30% of those with ulcerative colitis are over age 60.

If approved, tofacitinib would be the first oral Janus kinase inhibitor to be a therapeutic option for those with this type of colitis.


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