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:
09/23/2014

Orphan Drug exclusivity ends on:
09/23/2021
Company Making and Marketing this drug:
AbbVie, Inc.

FDA Designation Date:
10/19/06

FDA Drug Designation:
Treatment of pediatric Crohn's disease.