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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eflornithine plus sulindac
Date Designated: 01/22/2013
Orphan Designation: Treatment of familial adenomatous polyposis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
One-Two Therapeutics Assets Limited ("One-Two")
Carrick House, 49 Fitzwilliam Square
Dublin 2
Ireland

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.
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