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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  talimogene laherparepvec
Trade Name:  IMLYGIC
Date Designated:  03/14/2011
Orphan Designation:  Treatment of stage IIb-stage IV melanoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/27/2015 
Approved Labeled Indication:  Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery
Exclusivity End Date:    10/27/2022 
Exclusivity Protected Indication* :  Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery
BioVex, Inc. (subsidiary of Amgen)
Amgen
Mail Stop 17-2-B
Thousand Oaks, California 91320
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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