Search Orphan Drug Designations and Approvals
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Generic Name: | lomitapide | ||||||||||||||||
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Trade Name: | Juxtapid | ||||||||||||||||
Date Designated: | 10/23/2007 | ||||||||||||||||
Orphan Designation: | Treatment of homozygous familial hypercholesterolemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A Parma, Emilia Romagna 43122 Italy The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | lomitapide |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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