Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
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
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.

Marketing approved:

1 Generic Name: talimogene laherparepvec
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
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-