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: mecasermin rinfabate
Trade Name: Iplex
Date Designated: 05/17/2002
Orphan Designation: treatment of growth hormone insensitivity syndrome (GHIS)
Orphan Designation Status: Designated/Approved
Insmed, Inc.
10 Finderne Ave
Building 10
Bridgewater, New Jersey 08807
United States

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

Marketing approved:

1 Generic Name: mecasermin rinfabate
Trade Name: Iplex
Marketing Approval Date: 12/12/2005
Approved Labeled Indication: Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone
Exclusivity End Date: 12/12/2012 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-