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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: icatibant
Date Designated: 05/05/2004
Orphan Designation: Treatment of burn patients hospitalized with burn-induced edema
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shire Human Genetic Therapies
700 Main Street
Cambridge, Massachusetts 02139
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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