Lovaza

NDA 21654, held by Waylis Therap. Omega-3-Acid Ethyl Esters.

As of Nov 14, 2026, NDA 21654 (Lovaza), held by Waylis Therap, was first approved by FDA on Nov 10, 2004, with 21 approved supplements and 0 published complete response letters.

First approved: Nov 10, 2004
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

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


Sep 16, 2009	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 10, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lovaza1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS · capsule;oral	Omega-3-Acid Ethyl Esters	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Sep 4, 2020	Supplement 44Labeling · Standard review	Approved	Label Letter
Apr 3, 2019	Supplement 43Labeling · Standard review	Approved	Label Letter
Mar 9, 2015	Supplement 42Manufacturing · Standard review	Approved	None posted
Jun 5, 2014	Supplement 40Manufacturing · Standard review	Approved	None posted
May 14, 2014	Supplement 41Labeling · Standard review	Approved	Letter Label
Nov 15, 2013	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 11, 2013	Supplement 39Manufacturing · Standard review	Approved	Label
Jun 26, 2013	Supplement 37Labeling · Standard review	Approved	Label Letter
Aug 31, 2012	Supplement 34Labeling	Approved	Letter Label
Sep 19, 2011	Supplement 33Labeling	Approved	Letter
Aug 11, 2011	Supplement 31Labeling	Approved	None posted
Dec 22, 2010	Supplement 30Labeling	Approved	Letter Label
Sep 16, 2009	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 20, 2009	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 3, 2008	Supplement 21Labeling · Standard review	Approved	Label Letter
Jan 24, 2008	Supplement 18Manufacturing · Standard review	Approved	Review
Dec 6, 2007	Supplement 15Manufacturing	Approved	Letter
Nov 7, 2007	Supplement 14Labeling · Standard review	Approved	Letter Patient Information Sheet
Jun 12, 2007	Supplement 16Labeling · Standard review	Approved	Review Letter
Feb 1, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Jul 3, 2006	Supplement 7Manufacturing	Approved	Letter
Nov 10, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21654
Drugs@FDA: Overview at FDA
Company: Waylis Therapeutics

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