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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: itolizumab
Date Designated: 02/01/2019
Orphan Designation: Treatment of acute graft versus host disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biocon Limited
20th KM, Hosur Road
Electronic City, Bengaluru, Karnataka 560100
India

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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