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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Amphotericin B inhalation powder
Date Designated: 12/15/2005
Orphan Designation: Prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation for hematologic malignancies
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 12/14/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaceuticals Corporation
150 Industrial Road
San Carlos, California 94070
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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