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: |
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. |
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Marketing approved: |
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| 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* : | ||
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