Is Amikacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Amikacin, including AMCOCID 100MG-2ML INJ (50 mg/ml, Solution for injection, SAR 66.80); AMCOCID 500MG-2 ML AMP (250 mg/ml, Solution for injection, SAR 108.75); AMKANT (250 mg/ml, Solution for injection, SAR 97.85); ARIKAYCE (590 mg, Nebuliser suspension, SAR 53873.70); Amikacin (250 mg/ml, Solution for injection/infusion, SAR 19.55).

Is Amikacin approved by the US FDA?

Drugs@FDA lists 27 application product lines for Amikacin, including AMIKACIN SULFATE (Prescription); AMIKACIN SULFATE (Prescription); AMIKACIN SULFATE (Prescription); AMIKACIN SULFATE (Prescription); AMIKACIN SULFATE (Prescription).

Is Amikacin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Amikacin: Arikayce liposomal.

Is Amikacin on the WHO Model List of Essential Medicines?

Yes — 21.1. Ophthalmological preparations > Anti-infective agents (core list): Therapeutic equivalent to gentamicin for Other specified conjunctivitis; Therapeutic equivalent to gentamicin for Infectious blepharitis.

Are there safety signals or safety updates for Amikacin?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-06-25).

Active substance

Amikacin

SFDA 11
US FDA 27
EMA 2
Health Canada 4
US price lines 1
WHO EML 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AMCOCID 100MG-2ML INJ	50 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 66.80	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
AMCOCID 500MG-2 ML AMP	250 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 108.75	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
AMKANT	250 mg/ml	Solution for injection · Intramuscular and intravenous use	5 Vial	SAR 97.85	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
ARIKAYCE	590 mg	Nebuliser suspension · Inhalation use	28 Vial	SAR 53873.70	NCE · Prescription	Insmed Netherlands B.V	Valid
Amikacin	250 mg/ml	Solution for injection/infusion · Intramuscular and intravenous use	1 Vial	SAR 19.55	Generic · Prescription	Egyptian International Pharmaceutical Industries Company (EIPICO)	Valid
MIACIN 100MG-2ML AMP	50 mg/ml	Solution · Parenteral use	6 Ampoule	SAR 28.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
MIACIN 500MG-2ML AMP	250 mg/ml	Solution · Parenteral use	6 Ampoule	SAR 125.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SELEMYCIN	250 mg/ml	Solution for injection/infusion · Intramuscular and intravenous use	10 Ampoule	SAR 170.75	Generic · Prescription	Medochemie Ltd	Valid
AMIKACIN 500MG-2ML INJ VIAL (I.V,IM)	250 mg/ml	Solution for injection · Parenteral use	5 Vial	SAR 122.95	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
AMIKIN AMP 100MG-2ML	50 mg/ml	Solution · Parenteral use	1 Ampoule	SAR 20.05	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
AMIKIN AMP 500MG-2ML	250 mg/ml	Solution · Parenteral use	1 Ampoule	SAR 33.50	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PANCREATITIS; ACUTE PYELONEPHRITIS; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; HUMAN IMMUNODEFICIENCY VIRUS; INTRA-ABDOMINAL INFECTIONS; LOWER URINARY TRACT INFECTIONS; OSTEOMYELITIS; PERITONITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); Septic Shock; TRAVEL RELATED INFECTIONS-TREATMENT; TUBERCULOSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	MEITHEAL	Prescription	28 Sep 1993
AMIKACIN SULFATE	EQ 50MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	11 Apr 1994
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	11 Apr 1994
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	AVET LIFESCIENCES	Prescription	12 Dec 2013
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	9 Dec 2015
AMIKACIN SULFATE	EQ 250MG BASE/ML; 500MG(BASE)/ML(250MG/ML); 1G(BASE)/4ML(250MG/ML)	injectable · injection	SAGENT PHARMS INC	Prescription	12 May 2016
ARIKAYCE KIT	EQ 590MG BASE/8.4ML	suspension, liposomal · inhalation	INSMED INC	Prescription	28 Sep 2018
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	QILU	Prescription	19 Mar 2024
AMIKIN	EQ 50MG BASE/ML; EQ 250MG BASE/ML	injectable · injection	APOTHECON	Discontinued	22 Jan 1981
AMIKACIN SULFATE	EQ 50MG BASE/ML	injectable · injection	HIKMA PHARMS	Discontinued	18 May 1992
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	HIKMA PHARMS	Discontinued	18 May 1992
AMIKACIN SULFATE	EQ 50MG BASE/ML; EQ 250MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	30 Jul 1993
AMIKACIN SULFATE	EQ 50MG BASE/ML	injectable · injection	MEITHEAL	Discontinued	28 Sep 1993
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	ABBOTT	Discontinued	28 Oct 1994
AMIKACIN SULFATE	EQ 62.5MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	31 Oct 1994
AMIKACIN SULFATE	EQ 50MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	30 Nov 1994
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	30 Nov 1994
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	ABBOTT	Discontinued	30 Nov 1994
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	20 Jun 1995
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	26 Jun 1995
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	injectable · injection	HOSPIRA	Discontinued	2 Apr 1997
AMIKACIN SULFATE	EQ 50MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Discontinued	9 Dec 2015
AMIKIN	EQ 50MG BASE/ML; EQ 250MG BASE/ML	injectable · injection	APOTHECON	Discontinued
AMIKACIN SULFATE	EQ 50MG BASE/ML	injectable · injection	IGI LABS INC	Discontinued
AMIKACIN SULFATE	EQ 250MG BASE/ML	injectable · injection	IGI LABS INC	Discontinued

2 more — full table

EMA European Union — centrally authorised medicines

Arikayce liposomal Insmed Netherlands B.V. · Authorised · authorised 27 Oct 2020 · ATC J01GB06

Therapeutic indication (EMA)

Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

Arikayce Insmed Limited · Application withdrawn · ATC J01GB06

Therapeutic indication (EMA)

Arikayce is indicated for: treatment of Mycobacterium avium Complex (MAC) lung disease in adult patients who have persistent positive sputum cultures despite the use of medically appropriate first-line therapy Consideration should be given to official guidance on the appropriate use of antibacterial agents. Arikayce should be added to existing therapy and should not be used as monotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AMIKACIN SULFATE INJECTION	02486717	250 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	OMEGA LABORATORIES LIMITED
AMIKACIN SULFATE INJECTION	02529459	250 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	JAMP PHARMA CORPORATION
AMIKACIN SULFATE INJECTION USP	02242971	250 MG / ML	LIQUID · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
AMIKACIN SULFATE INJECTION USP	02481073	500 MG / 2 ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	MARCAN PHARMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMIKACIN SULF 500 MG/2 ML VIAL	$2.3276	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)

21.1. Ophthalmological preparations > Anti-infective agents · core
Therapeutic equivalent to gentamicin for Other specified conjunctivitis; Therapeutic equivalent to gentamicin for Infectious blepharitis
6.2.1. Access group antibiotics · core
First choice: Neutropaenia (high-risk); First choice: Acute pyelonephritis (severe) (co-prescribed with cefotaxime); First choice: Inflammatory or other diseases of prostate (severe) (co-prescribed with cefotaxime); First choice: Acute pyelonephritis (severe) (co-prescribed with ceftriaxone); First choice: Inflammatory or other diseases of prostate (severe) (co-prescribed with ceftriaxone)
Parenteral > General injections > unspecified: 250 mg per mL in 2 mL vial (as sulfate); 50 mg per mL in 2 mL vial (as sulfate) (EMLc) | Parenteral > General injections > unspecified: 250 mg per mL in 2 mL vial (as sulfate); 50 mg per mL in 2 mL vial (as sulfate) | Parenteral > General injections > unspecified: 250 mg per mL in 2 mL vial (as sulfate)
6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis
Parenteral > General injections > unspecified: 250 mg per mL in 2 mL vial (as sulfate)

Safety signals and safety-related labeling changes

US FDA 25 Jun 2026 ARIKAYCE KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Sep 2015 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 7 May 2015 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No

All safety entries for amikacin →

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.