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Uceris Approval History

FDA Approved: Yes (First approved January 14, 2013)
Brand name: Uceris
Generic name: budesonide
Company: Santarus, Inc.
Treatment for: Ulcerative Colitis

Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Development History and FDA Approval Process for Uceris

DateArticle
Oct  8, 2014Approval FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis
Jan 15, 2013Approval Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
Aug 13, 2012Santarus Announces FDA Extension of Uceris New Drug Application Target Action Date to January 16, 2013
Feb 15, 2012Santarus Announces FDA Acceptance of Uceris New Drug Application for Induction of Remission of Active Ulcerative Colitis
Dec 20, 2011Santarus Submits New Drug Application to FDA for Uceris (budesonide) Tablets

Further information

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