• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: idelalisib
Trade Name: Zydelig
Date Designated: 09/26/2013
Orphan Designation: Treatment of follicular 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 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.

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-