• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
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

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.