← FDA DRUG APPROVALS

FDA NDA · NDA203858

JUXTAPID

lomitapide mesylate

Sponsor: CHIESI

APPLICATION
NDA203858
TYPE
NDA
ORIGINAL APPROVAL
2012-12-21
LATEST ACTION
2026-02-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

JUXTAPID · ReferencePrescription
LOMITAPIDE MESYLATE EQ 2MG BASE · CAPSULE · ORAL
JUXTAPID · ReferenceDiscontinued
LOMITAPIDE MESYLATE EQ 40MG BASE · CAPSULE · ORAL
JUXTAPID · ReferencePrescription
LOMITAPIDE MESYLATE EQ 20MG BASE · CAPSULE · ORAL
JUXTAPID · ReferencePrescription
LOMITAPIDE MESYLATE EQ 5MG BASE · CAPSULE · ORAL
JUXTAPID · ReferenceDiscontinued
LOMITAPIDE MESYLATE EQ 60MG BASE · CAPSULE · ORAL
JUXTAPID · ReferencePrescription
LOMITAPIDE MESYLATE EQ 30MG BASE · CAPSULE · ORAL
JUXTAPID · ReferencePrescription
LOMITAPIDE MESYLATE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2026-02-25Efficacy · Supplement 27 · priority — Label ↗AP
2022-06-16REMS · Supplement 24 — Letter ↗AP
2022-02-01REMS · Supplement 23 — Letter ↗AP
2021-05-27REMS · Supplement 22 — Letter ↗AP
2019-12-20Labeling · Supplement 19 · standard — Label ↗AP
2018-06-04REMS · Supplement 18 — Letter ↗AP
2017-08-02Labeling · Supplement 17 · standard — Label ↗AP
2017-01-03REMS · Supplement 13 — Letter ↗AP
2017-01-03REMS · Supplement 16 — Letter ↗AP
2016-07-11Manufacturing (CMC) · Supplement 14 · standardAP
2016-05-23Labeling · Supplement 15 · 901 required — Label ↗AP
2016-03-08Labeling · Supplement 12 · standard — Label ↗AP
2015-04-24Manufacturing (CMC) · Supplement 11 · standardAP
2015-04-23Labeling · Supplement 10 · standard — Letter ↗AP
2014-11-11Manufacturing (CMC) · Supplement 8 · standardAP
2014-08-08Labeling · Supplement 9 · standard — Letter ↗AP
2014-04-23Manufacturing (CMC) · Supplement 5 · standardAP
2014-02-18Labeling · Supplement 6 · standard — Letter ↗AP
2013-12-17Manufacturing (CMC) · Supplement 4 · standardAP
2013-08-13REMS · Supplement 1 — Letter ↗AP
2013-04-10Labeling · Supplement 2 · standard — Label ↗AP
2012-12-21Type 1 - New Molecular Entity · Original · standard — Other ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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