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Ortikos FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 17, 2020.

FDA Approved: Yes (First approved June 13, 2019)
Brand name: Ortikos
Generic name: budesonide
Dosage form: Extended-Release Capsules
Company: Ferring Pharmaceuticals Inc.
Treatment for: Crohn's Disease, Active, Crohn's Disease, Maintenance

Ortikos (budesonide) is an oral corticosteroid indicated for the treatment of mild to moderate active Crohn’s disease.

Development timeline for Ortikos

Jul 29, 2020Approval Ortikos (budesonide), the First and Only Once-Daily Dose for Treatment of Mild to Moderate Crohn’s Disease, Now Available in the U.S.

Further information

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