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US FDA delays approval for expanded use of Pfizer's Xeljanz by 3 months

Pfizer Inc. said the U.S. Food and Drug Administration extended the expected approval date for Xeljanz's supplemental new drug application in ulcerative colitis by three months.

The company is seeking approval for Xeljanz to treat adult patients with moderately to severely active ulcerative colitis, an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract.

According to Pfizer, the FDA determined that additional review time was necessary due to information recently submitted by the company and as such constitutes a major amendment.

The agency has provided an anticipated Prescription Drug User Fee Act date in June 2018.

Xeljanz, or tofacitinib, is already approved to treat adult patients with moderate to severe active rheumatoid arthritis. It comes with a boxed warning about patients being treated with the drug being at an increased risk for developing serious infections that may lead to hospitalization or death.