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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	rituximab and recombinant human hyaluronidase
Trade Name:	Rituxan SC
Date Designated:	08/22/2016
Orphan Designation:	Treatment of follicular lymphoma
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.

1	Generic Name:	rituximab and recombinant human hyaluronidase
	Trade Name:	Rituxan SC
	Marketing Approval Date:	06/22/2017
	Approved Labeled Indication:	Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
	Exclusivity End Date:	06/22/2024
	Exclusivity Protected Indication* :	Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therap; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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