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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Mecasermin
Trade Name: Increlex
Date Designated: 12/12/1995
Orphan Designation: Treatment of growth hormone insensitivity syndrome.
Orphan Designation Status: Designated/Approved
Eton Pharmaceuticals, Inc.
21925 W. Field Parkway, Suite 235
Deer Park, Illinois 60010
United States

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

Marketing approved:

1 Generic Name: Mecasermin
Trade Name: Increlex
Marketing Approval Date: 08/30/2005
Approved Labeled Indication: Long-term 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: 08/30/2012 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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