Search Orphan Drug Designations and Approvals
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Generic Name: | talimogene laherparepvec | ||||||||||||||||
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Trade Name: | IMLYGIC | ||||||||||||||||
Date Designated: | 03/14/2011 | ||||||||||||||||
Orphan Designation: | Treatment of stage IIb-stage IV melanoma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | talimogene laherparepvec |
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Trade Name: | IMLYGIC | |
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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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