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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: perfluorooctyl-bromide
Date Designated: 08/08/2019
Orphan Designation: Treatment of congenital pulmonary hypoplasia in infancy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Children’s Hospital of Pennsylvania
Clinical Research Support
Colket Translational Research Building, 11th Floor, Room 11101
Philadelphia, Pennsylvania 19104
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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