Cardiolite, Miraluma

For an abnormal mammogram or a palpable breast mass. NDA 19785, held by Shine. Technetium Tc-99m Sestamibi Kit.

As of Nov 13, 2026, NDA 19785 (Cardiolite, Miraluma), held by Shine, was first approved by FDA on Dec 21, 1990, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1990
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE CARDIOLITE is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Apr 30, 2008	Supplement 18Efficacy (new indication or use)	Approved	Summary Review Label Letter
May 23, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 14, 1995	Supplement 5Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 14, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 9, 1992	Supplement 2Efficacy (new indication or use)	Approved	None posted
Dec 21, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


CardioliteN/A · injectable;injection	Technetium Tc-99m Sestamibi Kit	RxReference drug
MiralumaN/A · injectable;injection	Technetium Tc-99m Sestamibi Kit	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Dec 4, 2019	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 30, 2008	Supplement 18Efficacy (new indication or use)	Approved	Summary Review Label Letter
Jan 22, 2002	Supplement 12Labeling · Standard review	Approved	None posted
Jun 8, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 11, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 14, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Jun 10, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 8, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
May 23, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 24, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 8, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 26, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 28, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 14, 1995	Supplement 5Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 14, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 9, 1992	Supplement 2Efficacy (new indication or use)	Approved	None posted
Jan 30, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 21, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19785
Drugs@FDA: Overview at FDA
Company: SHINE Medical Technologies

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