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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  apremilast
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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