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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Cyclosporine
Date Designated:  11/25/2003
Orphan Designation:  Prophylaxis of organ rejection in patients receiving allogeneic lung transplant
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
APT Pharmaceuticals, Inc.
700 Airport Blvd.
Suite 350
Burlingame, California 94010
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.