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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  rituximab
Date Designated:  11/09/2016
Orphan Designation:  Treatment of Rasmussen's encephalitis
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Keck Graduate Institute of Applied Life Sciences
535 Watson Drive
Claremont, California 91711
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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