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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Velsipity (etrasimod) is an oral, once-daily, 2mg dose medication for adults with moderately to severely Active Ulcerative Colitis (UC). UC is a chronic condition, symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain, and urgency. As per press release by Pfizer, regulatory applications for Velsipity in ulcerative colitis is submitted to countries around the world, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), with a decision anticipated in the beginning of 2024.
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