Juxtapid

For homozygous familial hypercholesterolemia (HoFH). NDA 203858, held by Chiesi. Lomitapide Mesylate.

As of Nov 13, 2026, NDA 203858 (Juxtapid), held by Chiesi, was first approved by FDA on Dec 21, 2012, with 21 approved supplements and 0 published complete response letters.

First approved: Dec 21, 2012
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Feb 25, 2026	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 21, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Label Other Letter

Products

7 strengths and forms


JuxtapidEQ 5MG BASE · capsule;oral	Lomitapide Mesylate	RxReference drug
JuxtapidEQ 10MG BASE · capsule;oral	Lomitapide Mesylate	RxReference drug
JuxtapidEQ 20MG BASE · capsule;oral	Lomitapide Mesylate	RxReference drug
JuxtapidEQ 30MG BASE · capsule;oral	Lomitapide Mesylate	RxReference drug
JuxtapidEQ 40MG BASE · capsule;oral	Lomitapide Mesylate	DiscontinuedReference drug
JuxtapidEQ 60MG BASE · capsule;oral	Lomitapide Mesylate	DiscontinuedReference drug
JuxtapidEQ 2MG BASE · capsule;oral	Lomitapide Mesylate	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Feb 25, 2026	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 16, 2022	Supplement 24REMS	Approved	Letter
Feb 1, 2022	Supplement 23REMS	Approved	Review Letter
May 27, 2021	Supplement 22REMS	Approved	Letter
Dec 20, 2019	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 4, 2018	Supplement 18REMS	Approved	Letter
Aug 2, 2017	Supplement 17Labeling · Standard review	Approved	Medication Guide Letter Label
Jan 3, 2017	Supplement 16REMS	Approved	Letter
Jan 3, 2017	Supplement 13REMS	Approved	Letter
Jul 11, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
May 23, 2016	Supplement 15Labeling	Approved	Label Letter
Mar 8, 2016	Supplement 12Labeling · Standard review	Approved	Label Letter
Apr 24, 2015	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 23, 2015	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 11, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 8, 2014	Supplement 9Labeling · Standard review	Approved	Label Letter
Apr 23, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 18, 2014	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 17, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 13, 2013	Supplement 1REMS	Approved	Letter
Apr 10, 2013	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 21, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Label Other Letter

Identifiers

Application: NDA 203858
Drugs@FDA: Overview at FDA
Company: Chiesi

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters