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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 extranodal marginal zone lymphoma
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: umbralisib
Trade Name: Ukoniq
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or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen (Indication withdrawn)
Exclusivity End Date: 05/31/2022 
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or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen (Indication withdrawn)

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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