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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
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
Parma, Emilia Romagna 43122

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 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.