Myoview, Myoview 30ml

Used in scans for known or suspected coronary artery disease Assessment of left ventricular function (left ventricular ejection fraction and wall motion). NDA 20372, held by Medi-Physics. Technetium Tc-99m Tetrofosmin Kit.

As of Nov 13, 2026, NDA 20372 (Myoview, Myoview 30ml), held by Medi-Physics, was first approved by FDA on Feb 9, 1996, with 20 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1996
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Feb 28, 2003	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 23, 2001	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 9, 1996	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
MyoviewN/A · injectable;injection	Technetium Tc-99m Tetrofosmin Kit	RxReference drug
Myoview 30mlN/A · injectable;injection	Technetium Tc-99m Tetrofosmin Kit	RxReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 6, 2022	Supplement 33Labeling · Standard review	Approved	Label Letter
Mar 9, 2022	Supplement 31Labeling · Standard review	Approved	Label Letter
Apr 17, 2017	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 8, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 26, 2009	Supplement 22Manufacturing	Approved	Label Letter
Jul 7, 2005	Supplement 19Manufacturing · Standard review	Approved	Label Letter
Nov 13, 2003	Supplement 15Labeling · Standard review	Approved	Label Letter
Feb 28, 2003	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 25, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
May 22, 2002	Supplement 11Manufacturing · Standard review	Approved	Letter
Dec 4, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 23, 2001	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Aug 27, 2001	Supplement 9Manufacturing · Standard review	Approved	Label
Apr 10, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 29, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 13, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 12, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 9, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 7, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 9, 1996	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20372
Drugs@FDA: Overview at FDA
Company: Medi-Physics, Inc.

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