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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
Trade Name:  Ukoniq
Date Designated:  04/11/2019
Orphan Designation:  Treatment of nodal marginal zone lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/05/2021 
Approved Labeled Indication:  Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
Exclusivity End Date:    02/05/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
TG Therapeutics, Inc.
3020 Carrington Mill Blvd. Suite 475
Morrisville, North Carolina 27560
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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