Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
For homozygous familial hypercholesterolemia (HoFH). Sold as Juxtapid. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Lomitapide Mesylate (sold as Juxtapid), first approved Dec 21, 2012, with 1 new use approved and 0 published complete response letters.
First approved: Dec 21, 2012
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $17.1M
First approved in the EU: Jul 31, 2013
First approved in Japan: Sep 28, 2016
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 45 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Juxtapid, new ingredientDrugs with a new active ingredient indicated for the treatment of homozygous familial hypercholesterolemia. · Aegerion Pharmaceuticals K.K. · Sep 28, 2016
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Juxtapid REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Feb 25, 2026
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
