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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, Acute, Crohn's Disease, Maintenance

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

  • Ortikos (budesonide) is indicated for the:
    • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older.
    • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.
  • Ortikos is an oral capsule administered once daily in the morning. Capsules should be swallowed whole, and not crushed or chewed. Grapefruit juice should not be consumed during treatment with Ortikos.
  • Common adverse reactions (≥ 5%) in adults include headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.

Development Timeline for Ortikos

DateArticle
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.