Search Orphan Drug Designations and Approvals
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Generic Name: | umbralisib |
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Trade Name: | Ukoniq |
Date Designated: | 04/11/2019 |
Orphan Designation: | Treatment of nodal marginal zone lymphoma |
Orphan Designation Status: | Designated/Approved |
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 |
Exclusivity End Date: | 02/05/2028 |
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 |
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. |
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