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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 in combination with omega-3 polyunsaturated fatty acids
Date Designated: 12/06/2000
Orphan Designation: Prevention of solid organ graft rejection.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
RTP Pharma Corporation
200 Westpark Corporate Center
4364 South Alston Avenue
Durham, North Carolina 27713
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.