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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  brentuximab vedotin
Trade Name:  Adcetris
Date Designated:  01/30/2007
Orphan Designation:  Treatment of Hodgkin's lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/19/2011 
Approved Labeled Indication:  The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
Exclusivity End Date:    08/19/2018 
Exclusivity Protected Indication* :  
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  brentuximab vedotin
Trade Name:  Adcetris
Date Designated:  01/30/2007
Orphan Designation:  Treatment of Hodgkin's lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/17/2015 
Approved Labeled Indication:  Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity End Date:    08/17/2022 
Exclusivity Protected Indication* :  Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  brentuximab vedotin
Trade Name:  Adcetris
Date Designated:  01/30/2007
Orphan Designation:  Treatment of Hodgkin's lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  03/20/2018 
Approved Labeled Indication:  ADCETRIS® is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity End Date:    03/20/2025 
Exclusivity Protected Indication* :  ADCETRIS® is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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