Search Orphan Drug Designations and Approvals
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Generic Name: | ibritumomab tiuxetan | ||||||||||||||||
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Trade Name: | Zevalin | ||||||||||||||||
Date Designated: | 09/06/1994 | ||||||||||||||||
Orphan Designation: | Treatment of B-cell non-Hodgkin's lymphoma. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Acrotech Biopharma LLC 279 Princeton Hightstown Road East Windsor, New Jersey 08520 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: | ibritumomab tiuxetan |
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Trade Name: | Zevalin | |
Marketing Approval Date: | 02/19/2002 | |
Approved Labeled Indication: | Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma | |
Exclusivity End Date: | 02/19/2009 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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