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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: lomitapide
Trade Name: Juxtapid
Date Designated: 10/23/2007
Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Orphan Designation Status: Designated/Approved
Aegerion Pharmaceuticals, Inc.
101 Main St., Suite 1850
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: lomitapide
Trade Name: Juxtapid
Marketing Approval Date: 12/21/2012
Approved Labeled Indication: Adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
Exclusivity End Date: 12/21/2019 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.