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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: 03/04/2020
Orphan Designation: Treatment of Follicular 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or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy (Indication withdrawn)
Exclusivity End Date: 05/31/2022 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy (Indication withdrawn)
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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