Definity, Definity Rt

For suboptimal echocardiograms. NDA 21064, held by Lantheus Medcl. Perflutren.

As of Nov 14, 2026, NDA 21064 (Definity, Definity Rt), held by Lantheus Medcl, was first approved by FDA on Jul 31, 2001, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2001
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Mar 1, 2024	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 24, 2011	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Summary Review Letter Label
Jul 31, 2001	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Products

2 strengths and forms


Definity13.04MG/2ML (6.52MG/ML) · injectable;intravenous	Perflutren	RxReference drug
Definity Rt13.04MG/2ML (6.52MG/ML) · injectable;intravenous	Perflutren	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Mar 1, 2024	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 5, 2023	Supplement 32Labeling · Standard review	Approved	Label Letter
Apr 9, 2021	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 9, 2021	Supplement 29Labeling · Standard review	Approved	Letter Label
Nov 17, 2020	Supplement 24Labeling · Standard review	Approved	Label Review Letter
Jul 30, 2020	Supplement 23Labeling · Standard review	Approved	Label Letter
Dec 12, 2018	Supplement 22Labeling · Standard review	Approved	Label Letter
Apr 13, 2018	Supplement 21Manufacturing	Approved	None posted
Jan 19, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 23, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 18, 2015	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 5, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 24, 2011	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Summary Review Letter Label
May 12, 2008	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 10, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
May 6, 2005	Supplement 6Labeling · Standard review	Approved	Label
Jan 30, 2003	Supplement 4Manufacturing · Standard review	Approved	Letter
Jul 8, 2002	Supplement 2Labeling · Standard review	Approved	Letter
Feb 21, 2002	Supplement 1Labeling · Standard review	Approved	Letter
Jul 31, 2001	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 21064
Drugs@FDA: Overview at FDA
Company: Lantheus Medical Imaging

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