• 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:  duvelisib
Trade Name:  COPIKTRA
Date Designated:  04/15/2013
Orphan Designation:  Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/24/2018 
Approved Labeled Indication:  Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies
Exclusivity End Date:    09/24/2025 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies
Verastem, Inc.
117 Kendrick Street
Suite 500
Needham, Massachusetts 02494
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.
-
-