Search Orphan Drug Designations and Approvals
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Generic Name: | rituximab and recombinant human hyaluronidase | ||||||||||||||||
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Trade Name: | Rituxan SC | ||||||||||||||||
Date Designated: | 08/22/2016 | ||||||||||||||||
Orphan Designation: | Treatment of chronic lymphocytic leukemia (CLL) | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Genentech, Inc. 1 DNA Way South San Francisco, California 94080 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: | rituximab and recombinant human hyaluronidase |
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Trade Name: | Rituxan SC | |
Marketing Approval Date: | 06/22/2017 | |
Approved Labeled Indication: | Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide | |
Exclusivity End Date: | 06/22/2024 | |
Exclusivity Protected Indication* : | Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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