Search Orphan Drug Designations and Approvals
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Generic Name: | infliximab | ||||||||||||||||
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Trade Name: | Remicade | ||||||||||||||||
Date Designated: | 11/12/2003 | ||||||||||||||||
Orphan Designation: | Treatment of pediatric (0 to 16 years of age) ulcerative colitis | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Janssen Biotech, Inc. 200 Great Valley Parkway Malvern, Pennsylvania 19355 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | infliximab |
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Trade Name: | Remicade | |
Marketing Approval Date: | 09/23/2011 | |
Approved Labeled Indication: | For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy | |
Exclusivity End Date: | 09/23/2018 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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