Is Technetium tc 99m sestamibi kit approved by the US FDA?

Drugs@FDA lists 6 application product lines for Technetium tc 99m sestamibi kit, including CARDIOLITE (Prescription); TECHNETIUM TC 99M SESTAMIBI (Prescription); TECHNETIUM TC 99M SESTAMIBI (Prescription); TECHNETIUM TC 99M SESTAMIBI (Prescription); MIRALUMA (Discontinued).

Are there safety signals or safety updates for Technetium tc 99m sestamibi kit?

US FDA: 1 entry (latest 2019-12-04).

Active substance

Technetium tc 99m sestamibi kit

US FDA 6
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CARDIOLITE	N/A	injectable · injection	SHINE	Prescription	21 Dec 1990
TECHNETIUM TC 99M SESTAMIBI	N/A	injectable · injection	CURIUM	Prescription	22 Sep 2008
TECHNETIUM TC 99M SESTAMIBI	N/A	injectable · injection	CARDINAL HEALTH 414	Prescription	28 Apr 2009
TECHNETIUM TC 99M SESTAMIBI	N/A	injectable · injection	JUBILANT DRAXIMAGE	Prescription	29 Apr 2009
MIRALUMA	N/A	injectable · injection	SHINE	Discontinued	21 Dec 1990
TECHNETIUM TC 99M SESTAMIBI	10-30mCi	injectable · injection	SUN PHARM INDS INC	Discontinued	10 Jul 2009

Safety signals and safety-related labeling changes

US FDA 4 Dec 2019 CARDIOLITE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for technetium tc 99m sestamibi kit →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.