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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: an antibiotic combination product consisting of 3 antimicrobial agents (clarithromycin, rifabutin, and clofazimine).
Date Designated: 10/13/2020
Orphan Designation: Treatment for Nontuberculous Mycobacteria Disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
RedHill Biopharma Ltd.
21 Ha'arba'a St.
Tel-Aviv 64739

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.