Livalo

For primary hyperlipidemia. NDA 22363, held by Kowa Co. Pitavastatin Calcium.

As of Nov 14, 2026, NDA 22363 (Livalo), held by Kowa Co, was first approved by FDA on Aug 3, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2009
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


May 16, 2019	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric CDTL Review
Nov 18, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 3, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Products

3 strengths and forms


LivaloEQ 1MG BASE · tablet;oral	Pitavastatin Calcium	RxReference drug
LivaloEQ 2MG BASE · tablet;oral	Pitavastatin Calcium	RxReference drug
LivaloEQ 4MG BASE · tablet;oral	Pitavastatin Calcium	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Mar 14, 2024	Supplement 22Labeling · Standard review	Approved	Label Letter
Nov 9, 2022	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 25, 2020	Supplement 18Labeling	Approved	Label Letter
Oct 18, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
May 16, 2019	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric CDTL Review
Nov 18, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 21, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 16, 2013	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 31, 2012	Supplement 10Labeling	Approved	Letter Label
Feb 28, 2012	Supplement 9Labeling	Approved	Review Letter Label
Feb 28, 2012	Supplement 8Labeling	Approved	Review Letter Label
Aug 3, 2011	Supplement 6Labeling	Approved	Label Letter
Jun 16, 2011	Supplement 5Labeling	Approved	Letter Label
Jun 1, 2010	Supplement 2Labeling · Standard review	Approved	Letter
Aug 3, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: LIVALOSep 24, 2019

Identifiers

Application: NDA 22363
Drugs@FDA: Overview at FDA
Company: Kowa Company

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