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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
Israel

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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