Is Indium in 111 pentetreotide kit approved by the US FDA?

Drugs@FDA lists 2 application product lines for Indium in 111 pentetreotide kit, including OCTREOSCAN (Prescription); INDIUM IN-111 PENTETREOTIDE KIT (Discontinued).

Are there safety signals or safety updates for Indium in 111 pentetreotide kit?

US FDA: 1 entry (latest 2022-02-09).

Active substance

Indium in 111 pentetreotide kit

US FDA 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
OCTREOSCAN	3mCi/ML	injectable · injection	CURIUM	Prescription	2 Jun 1994
INDIUM IN-111 PENTETREOTIDE KIT	3mCi/ML	injectable · injection	SUN PHARM INDS INC	Discontinued	1 Jul 2024

Safety signals and safety-related labeling changes

US FDA 9 Feb 2022 OCTREOSCAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for indium in 111 pentetreotide 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.