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: Lanreotide
Trade Name: Somatuline Depot
Date Designated: 09/11/2000
Orphan Designation: Treatment for acromegly
Orphan Designation Status: Designated/Approved
IPSEN, Inc.
27 Maple Street
Milford, Massachusetts 01757
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Lanreotide
Trade Name: Somatuline Depot
Marketing Approval Date: 08/30/2007
Approved Labeled Indication: Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy
Exclusivity End Date: 08/30/2014 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-