• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
 
Generic Name:  umbralisib
Trade Name:  Ukoniq
Date Designated:  03/04/2020
Orphan Designation:  Treatment of Follicular Lymphoma
Orphan Designation Status:  Designated/Approved
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.
Exclusivity End Date:    02/05/2028 
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.
TG Therapeutics, Inc.
343 Thornall Street, Suite 740
Edison, New Jersey 08837
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.
-
-