Search Orphan Drug Designations and Approvals
-
| Generic Name: | umbralisib | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trade Name: | Ukoniq | ||||||||||||||||
| Date Designated: | 04/11/2019 | ||||||||||||||||
| Orphan Designation: | Treatment of nodal marginal zone lymphoma | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen (Indication withdrawn) | |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or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen (Indication withdrawn) | |
-
