Is Zoledronic acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Zoledronic acid, including ACIDOXAX 4MG VIAL (4 mg, Concentrate for solution for infusion, SAR 57.95); ACLASTA 5MG-100ML SOLUTION FOR Infusion* (0.05 mg/ml, Solution for infusion, SAR 1482.25); OSTADIL 4 mg concentrate for IV infusion (0.8 mg/ml, Concentrate for solution for infusion, SAR 713.60); ZIDRONIC 4 mg/5 ml Vial (0.8 mg/ml, Solution for infusion, SAR 713.60); ZOLEDRON 4 mg per 5 ml (0.8 mg/ml, Solution for injection, SAR 713.60).

Is Zoledronic acid approved by the US FDA?

Drugs@FDA lists 43 application product lines for Zoledronic acid, including ZOMETA (Prescription); RECLAST (Prescription); RECLAST (Prescription); ZOLEDRONIC ACID (Prescription); ZOLEDRONIC ACID (Prescription).

Is Zoledronic acid authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Zoledronic acid: Zometa, Aclasta, Zoledronic acid Teva, Zoledronic acid Mylan, Zoledronic Acid Accord.

Is Zoledronic acid on the WHO Model List of Essential Medicines?

Yes — 8.2.5. Supportive medicines (complementary list): Malignant neoplasm metastasis in bone or bone marrow.

Are there safety signals or safety updates for Zoledronic acid?

EMA PRAC: 2 entries; US FDA: 4 entries (latest 2026-02-03).

Active substance

Zoledronic acid

SFDA 15
US FDA 43
EMA 10
Health Canada 9
US price lines 1
WHO EML 1
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ACIDOXAX 4MG VIAL	4 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 57.95	Generic · Prescription	Boston Oncology Arabia	Valid
ACLASTA 5MG-100ML SOLUTION FOR Infusion*	0.05 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 1482.25	Generic · Prescription	Sandoz Pharmaceuticals	Valid
OSTADIL 4 mg concentrate for IV infusion	0.8 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 713.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ZIDRONIC 4 mg/5 ml Vial	0.8 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 713.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ZOLEDRON 4 mg per 5 ml	0.8 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 713.60	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
ZOLEDRONIC ACID FRESENIUS KABI 4 MG/5 ML CONC. FOR SOLUTION FOR INFUSION	0.8 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 78.65	Generic · Prescription	FRESENIUS KABI	Valid
ZOLEDRONIC ACID SPC 5MG/100ML SOL. FOR INFUSION	0.05 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 925.25	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
ZOTIMOS 4MG VIAL	4 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 82.20	Generic · Prescription	LES LABORATOIRES MEDIS	Valid
Zodric 5 mg per 100 ml	0.05 mg/ml	Solution for infusion · Intravenous use	1 Bag	SAR 1189.60	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
VISKEN 5MG TABLETS	5 mg	Tablet · Oral use	30 Blister	SAR 20.60	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
ZOLENAT 4 mg/5ml Concentrate for Solution for Infusion	0.8 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 82.80	Generic · Prescription	GENSENTA İLAÇ SANAYI VE TICARET A.Ş	Withdrawn by MAH · Not Marketed
ZOLENAT 4 mg/5ml Concentrate for Solution for Infusion	0.8 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 82.80	Generic · Prescription	GENSENTA İLAÇ SANAYI VE TICARET A.Ş	Withdrawn by MAH · Not Marketed
ZOMETA 4MG VIAL\5ML	4 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 792.90	Generic · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
Zoledronic Acid SPC	0.04 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 705.50	Generic · Prescription	SUDAIR PHARMA COMPANY	Withdrawn by MAH · Not Marketed
Zonrex	0.8 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 824.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BREAST CANCER MET. HORMONAL-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET. HORMONAL-SUPPORTIVE CARE; BREAST CANCER MET.HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 -VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER TARGET THERAPY-ADVERSE REACTION MANAGEMENT; BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; GAUCHER DISEASE - OSTEOPOROSIS; HYPERPARATHYRODISM; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA-HYPERCALCEMIA OF MALIGNANCY; OSTEOPOROSIS; PARATHYROID CANCER - HYPERCALCEMIA; PROSTATE CANCER; SPINAL MUSCULAR ATROPHY - MAINTENANCE OF BONE HEALTH; THYROID CANCER-MEDULLARY CARCINOMA-SUPPORTIVE CARE

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

Product	Strength	Form · route	Applicant	Status	First approved
ZOMETA	EQ 4MG BASE/VIAL	injectable · iv (infusion)	NOVARTIS	Prescription	22 Feb 2002
RECLAST	EQ 5MG BASE/100ML	injectable · intravenous	SANDOZ	Prescription	16 Apr 2007
RECLAST	5MG/100ML	injectable · injection	SANDOZ	Prescription	17 Aug 2007
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	DR REDDYS LABS LTD	Prescription	4 Mar 2013
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	MYLAN LABS LTD	Prescription	4 Mar 2013
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	AVET LIFESCIENCES	Prescription	12 Mar 2013
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	DR REDDYS LABS LTD	Prescription	29 Mar 2013
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	CHARTWELL RX	Prescription	7 May 2013
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	HIKMA FARMACEUTICA	Prescription	3 Jun 2013
ZOLEDRONIC ACID	EQ 4MG BASE/100ML	injectable · intravenous	INFORLIFE	Prescription	2 Aug 2013
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	CHARTWELL RX	Prescription	5 Aug 2013
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	GLAND	Prescription	5 Aug 2013
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	INFORLIFE	Prescription	23 Sep 2013
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	EPIC PHARMA LLC	Prescription	22 May 2014
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	EPIC PHARMA LLC	Prescription	21 Aug 2014
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	USV	Prescription	4 Sep 2014
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	SAGENT PHARMS INC	Prescription	24 Nov 2014
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	FRESENIUS KABI USA	Prescription	23 Apr 2015
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	GLAND	Prescription	18 Aug 2016
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	ACCORD HLTHCARE	Prescription	28 Nov 2016
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	MYLAN LABS LTD	Prescription	14 Feb 2017
ZOLEDRONIC ACID	EQ 5MG BASE/100ML	injectable · intravenous	MYLAN LABS LTD	Prescription	27 Oct 2017
ZOLEDRONIC ACID	EQ 4MG BASE/100ML	injectable · intravenous	AMNEAL	Prescription	27 Oct 2017
ZOLEDRONIC ACID	EQ 4MG BASE/5ML	injectable · intravenous	BPI LABS	Prescription	29 Dec 2017
ZOLEDRONIC	EQ 4MG BASE/100ML	injectable · intravenous	GLAND	Prescription	29 Jun 2018

18 more — full table

EMA European Union — centrally authorised medicines

Zometa Phoenix Labs Unlimited Company · Authorised · authorised 20 Mar 2001 · ATC M05BA08

Therapeutic indication (EMA)

Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Aclasta Sandoz Pharmaceuticals d.d. · Authorised · authorised 15 Apr 2005 · ATC M05BA08

Therapeutic indication (EMA)

Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone.

Zoledronic acid Teva Teva B.V. · Authorised · authorised 16 Aug 2012 · ATC M05BA08

Therapeutic indication (EMA)

Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.

Zoledronic acid Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 23 Aug 2012 · ATC M05BA08

Therapeutic indication (EMA)

Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Zoledronic Acid Accord Accord Healthcare S.L.U. · Authorised · authorised 16 Jan 2014 · ATC M05BA08

Therapeutic indication (EMA)

Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Zoledronic acid Actavis Actavis Group PTC ehf · Withdrawn · authorised 20 Apr 2012 · ATC M05BA08

Therapeutic indication (EMA)

Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia.

Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH · Withdrawn · authorised 3 Aug 2012 · ATC M05BA08

Therapeutic indication (EMA)

Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Zoledronic acid Teva Pharma Teva B.V. · Withdrawn · authorised 15 Aug 2012 · ATC M05BA08

Therapeutic indication (EMA)

Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget’s disease of the bone in adults.

Zoledronic Acid Hospira Pfizer Europe MA EEIG · Withdrawn · authorised 19 Nov 2012 · ATC M05BA08

Therapeutic indication (EMA)

4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 5 mg / 100 ml: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.

Zoledronic acid Teva Generics Teva Generics B.V · Withdrawn · authorised 27 Mar 2014 · ATC M05BA08

Therapeutic indication (EMA)

Treatment of osteoporosis in post-menopausal women in adult men at increased risk of fracture, including those with recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women in adult men at increased risk of fracture. Treatment of Paget's disease of the bone in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACLASTA	02269198	5 MG / 100 ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
JAMP-ZOLEDRONIC ACID	02482525	4 MG / 5 ML	SOLUTION · INTRAVENOUS	JAMP PHARMA CORPORATION
TARO-ZOLEDRONIC ACID CONCENTRATE	02415186	4 MG / 5 ML	SOLUTION · INTRAVENOUS	TARO PHARMACEUTICALS INC
ZOLEDRONIC ACID - Z	02401606	4 MG / 5 ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
ZOLEDRONIC ACID FOR INJECTION	02434458	4 MG / 5 ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
ZOLEDRONIC ACID FOR INJECTION	02472805	4 MG / 5 ML	SOLUTION · INTRAVENOUS	MARCAN PHARMACEUTICALS INC
ZOLEDRONIC ACID FOR INJECTION CONCENTRATE	02422425	4 MG / 5 ML	SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
ZOLEDRONIC ACID INJECTION	02422433	5 MG / 100 ML	SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
ZOMETA CONCENTRATE	02248296	4 MG / 5 ML	SOLUTION · INTRAVENOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ZOLEDRONIC ACID 5 MG/100 ML	$0.47512	per ML	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

8.2.5. Supportive medicines · complementary
Malignant neoplasm metastasis in bone or bone marrow
Parenteral > General injections > IV: 4 mg per 5 mL in 5 mL vial; 4 mg per 100 mL in 100 mL bottle

Safety signals and safety-related labeling changes

US FDA 3 Feb 2026 RECLAST — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Oct 2020 ZOLEDRONIC ACID — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Dec 2018 ZOLEDRONIC ACID — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Dec 2018 ZOMETA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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 zoledronic 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.