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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant humanized anti-complement component 5 monoclonal antibody
Date Designated: 09/05/2017
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria (PNH)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hoffmann-La Roche Inc.
c/o Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
United States

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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