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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:  10/23/2008
Orphan Designation:  Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/19/2011 
Approved Labeled Indication:  The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
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:  10/23/2008
Orphan Designation:  Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/16/2018 
Approved Labeled Indication:  ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
Exclusivity End Date:    11/16/2025 
Exclusivity Protected Indication* :  ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
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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