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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  idelalisib
Trade Name:  Zydelig
Date Designated:  09/26/2013
Orphan Designation:  Treatment of follicular lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/23/2014 
Approved Labeled Indication:  Zydelig is indicated for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies.
Exclusivity End Date:    07/23/2021 
Exclusivity Protected Indication* :  Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies.
Gilead Sciences, Inc.
199 E. Blaine St
Seattle, Washington 98102
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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