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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ustekinumab
Trade Name: Stelara
Date Designated: 05/18/2016
Orphan Designation: Treatment of pediatric Crohn's disease (0 through 16 years of age)
Orphan Designation Status: Designated/Approved
Janssen Research & Development, LLC
1400 McKean Road
P.O. Box 776
Spring House, Pennsylvania 19477
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: ustekinumab
Trade Name: Stelara
Marketing Approval Date: 04/15/2026
Approved Labeled Indication: treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease
Exclusivity End Date: 04/15/2033 
Exclusivity Protected Indication* :  treatment of pediatric patients 2 years of age and older with moderately to severely active Crohn's disease
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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