FDA Approved Indications for this Orphan Drug:Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. (Orphan approval for patients from 6 through 16 years of age.)
FDA Marketing Approval issued as of:
Orphan Drug exclusivity ends on:
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FDA Designation Date:
FDA Drug Designation:
Treatment of pediatric Crohn's disease.