Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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: ofatumumab
Trade Name: ARZERRA
Date Designated: 03/10/2009
Orphan Designation: Treatment of chronic lymphocytic leukemia
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: ofatumumab
Trade Name: ARZERRA
Marketing Approval Date: 10/26/2009
Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine
Exclusivity End Date: 10/26/2016 
Exclusivity Protected Indication* :  
2 Generic Name: ofatumumab
Trade Name: ARZERRA
Marketing Approval Date: 04/17/2014
Approved Labeled Indication: ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity End Date: 04/17/2021 
Exclusivity Protected Indication* :  Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
3 Generic Name: ofatumumab
Trade Name: ARZERRA
Marketing Approval Date: 01/19/2016
Approved Labeled Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
Exclusivity End Date: 01/19/2023 
Exclusivity Protected Indication* :  For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
4 Generic Name: ofatumumab
Trade Name: ARZERRA
Marketing Approval Date: 08/30/2016
Approved Labeled Indication: Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-