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 |
| 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. |
| Sponsor: |
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. |
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