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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Berubicin
Date Designated: 06/09/2020
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CNS Pharmaceuticals, Inc.
2100 West Loop South
Suite 900
Houston, Texas 77027
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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