1. Pink Sheet

Pfizer Xeljanz's Long-term Dosing Raises Safety Concerns In Ulcerative Colitis

 
• By Derrick Gingery

US FDA's Gastrointestinal Drugs Advisory Committee will weigh proposed indication as agency appears uncertain whether higher dose can be used as long-term therapy.

FDA Advisory Committee Feature image

The US FDA's safety concerns about a proposed long-term maintenance dose for Pfizer Inc.'s Xeljanz (tofacitinib) in ulcerative colitis may limit the dosing regimens that are ultimately approved.

Dosing issues are one of several items the Gastrointestinal Drugs Advisory Committee will discuss during a March 8 meeting

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