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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: 10/15/2013
Orphan Designation: Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: idelalisib
Trade Name: Zydelig
Marketing Approval Date: 07/23/2014
Approved Labeled Indication: Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities; and Zydelig is indicated for the treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.
Exclusivity End Date: 07/23/2021 
Exclusivity Protected Indication* :  (1) Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities; and (2) Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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