Search Orphan Drug Designations and Approvals
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Generic Name: | ofatumumab | ||||||||||||||||
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Trade Name: | ARZERRA | ||||||||||||||||
Date Designated: | 03/10/2009 | ||||||||||||||||
Orphan Designation: | Treatment of chronic lymphocytic leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | ofatumumab |
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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 |
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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 |
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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 |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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