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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: clarithromycin, rifabutin, clofazimine
Date Designated: 04/26/2011
Orphan Designation: Treatment of pediatric Crohn's disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv-Yafo
Tel Aviv District
Israel

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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