Search Orphan Drug Designations and Approvals
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Generic Name: | apremilast |
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Trade Name: | OTEZLA® |
Date Designated: | 01/17/2013 |
Orphan Designation: | Treatment of Behcet's disease |
Orphan Designation Status: | Designated/Approved |
Marketing Approval Date: | 07/19/2019 |
Approved Labeled Indication: | OTEZLA is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. |
Exclusivity End Date: | 07/19/2026 |
Exclusivity Protected Indication* : | For the treatment of adult patients with oral ulcers associated with Behçet’s disease |
Sponsor: |
Amgen Inc. One Amgen Center Drive Mailstop: 27-2-D Thousand Oaks, California 91320 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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