Is Pamidronic acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Pamidronic acid.

Is Pamidronic acid approved by the US FDA?

Drugs@FDA lists 16 application product lines for Pamidronic acid, including AREDIA (Prescription); PAMIDRONATE DISODIUM (Prescription); PAMIDRONATE DISODIUM (Prescription); PAMIDRONATE DISODIUM (Prescription); PAMIDRONATE DISODIUM (Prescription).

Are there safety signals or safety updates for Pamidronic acid?

EMA PRAC: 2 entries (latest 2015-09-10).

Active substance

Pamidronic acid

SFDA 2
US FDA 16
Health Canada 8
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AREDIA 15MG VIAL+SOLVENT	15 mg	Injection · Intravenous use	4 Vial	SAR 631.75	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
AREDIA 30MG VIAL+SOLVENT	30 mg	Injection · Intravenous use	2 Vial	SAR 568.60	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
AREDIA	30MG/VIAL; 60MG/VIAL; 90MG/VIAL	injectable · injection	NOVARTIS	Prescription	22 Sep 1998
PAMIDRONATE DISODIUM	30MG/VIAL; 90MG/VIAL	injectable · injection	HIKMA PHARMS	Prescription	30 Apr 2001
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	HIKMA PHARMS	Prescription	4 Mar 2002
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 60MG/10ML (6MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	HOSPIRA	Prescription	27 Jun 2002
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 60MG/10ML (6MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	DR REDDYS	Prescription	19 Aug 2008
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	MYLAN LABS LTD	Prescription	31 Oct 2008
PAMIDRONATE DISODIUM	30MG/VIAL; 60MG/VIAL; 90MG/VIAL	injectable · injection	AREVA PHARMS	Prescription	26 Nov 2008
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	SAGENT PHARMS INC	Prescription	23 Dec 2008
AREDIA	30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 60MG/VIAL; 90MG/VIAL	injectable · injection	NOVARTIS	Discontinued	31 Oct 1991
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	TEVA PHARMS USA	Discontinued	27 Mar 2002
PAMIDRONATE DISODIUM	30MG/VIAL; 90MG/VIAL	injectable · injection	AESGEN	Discontinued	6 May 2002
PAMIDRONATE DISODIUM	30MG/VIAL; 90MG/VIAL	injectable · injection	FRESENIUS KABI USA	Discontinued	6 May 2002
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	FRESENIUS KABI USA	Discontinued	17 May 2002
PAMIDRONATE DISODIUM	30MG/10ML (3MG/ML); 90MG/10ML (9MG/ML)	injectable · injection	AM REGENT	Discontinued	25 Jul 2008
PAMIDRONATE DISODIUM	30MG/VIAL; 90MG/VIAL	injectable · injection	SUN PHARMA GLOBAL	Discontinued	24 Dec 2008
PAMIDRONATE DISODIUM	30MG/VIAL; 90MG/VIAL	injectable · injection	MN PHARMS	Discontinued	10 Mar 2009

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PAMIDRONATE DISODIUM FOR INJECTION	02244550	3 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
PAMIDRONATE DISODIUM FOR INJECTION	02244551	6 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
PAMIDRONATE DISODIUM FOR INJECTION	02244552	9 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
PAMIDRONATE DISODIUM FOR INJECTION	02246597	3 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
PAMIDRONATE DISODIUM FOR INJECTION	02246598	6 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
PAMIDRONATE DISODIUM FOR INJECTION	02246599	9 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
PAMIDRONATE DISODIUM OMEGA 6 MG/ML	02249677	6 MG / ML	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED
PAMIDRONATE DISODIUM OMEGA 9 MG/ML	02249685	9 MG / ML	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED

Safety signals and safety-related labeling changes

EMA PRAC 10 Sep 2015 PRAC signal: Osteonecrosis of the external auditory canal
Action for MAH: update of the product information: Yes
EMA PRAC 12 Mar 2015 PRAC signal: Osteonecrosis of the external auditory canal
Action for MAH: update of the product information: No

All safety entries for pamidronic acid →

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.