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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name:  umbralisib
Date Designated:  04/11/2019
Orphan Designation:  Treatment of nodal marginal zone lymphoma
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
TG Therapeutics, Inc.
2 Gansevoort Street
9th Floor
New York, New York 10014
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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