Is Daptomycin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Daptomycin, including DACI (500 mg, Powder for solution for injection/infusion, SAR 372.40); DAPTOMYCIN BOS (350 mg, Powder for solution for injection/infusion, SAR 173.35); DOCINE 500 mg Vial (500 mg, Powder for solution for injection/infusion, SAR 392.00); Daptomycin Amarox (500 mg, Powder for solution for injection/infusion, SAR 346.75); Daptomycin Amarox (350 mg, Powder for solution for injection/infusion, SAR 242.70).

Is Daptomycin approved by the US FDA?

Drugs@FDA lists 35 application product lines for Daptomycin, including DAPTOMYCIN (Prescription); DAPTOMYCIN (Prescription); DAPTOMYCIN (Prescription); DAPTOMYCIN (Prescription); DAPTOMYCIN (Prescription).

Is Daptomycin authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Daptomycin: Cubicin, Daptomycin Hospira.

Are there safety signals or safety updates for Daptomycin?

EMA PRAC: 1 entry; US FDA: 6 entries; MHRA: 1 entry (latest 2025-05-12).

Active substance

Daptomycin

SFDA 8
US FDA 35
EMA 2
Health Canada 3
US price lines 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DACI	500 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 372.40	NCE · Prescription	MS Pharma Saudi (MSPS)	Valid
DAPTOMYCIN BOS	350 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 173.35	Generic · Prescription	Boston Oncology Arabia	Valid
DOCINE 500 mg Vial	500 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 392.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Daptomycin Amarox	500 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 346.75	Generic · Prescription	Saudi Amarox	Valid
Daptomycin Amarox	350 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 242.70	Generic · Prescription	Saudi Amarox	Valid
Valencin	500 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 242.70	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
DAPTOCIDAL	350 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 188.40	NCE · Prescription	GENSENTA İLAÇ SANAYI VE TICARET A.Ş	Withdrawn by MAH · Not Marketed
DAPTOCIDAL	500 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 255.85	NCE · Prescription	GENSENTA İLAÇ SANAYI VE TICARET A.Ş	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; ENDOCARDITIS; INTRA-ABDOMINAL INFECTIONS; OSTEOMYELITIS; PERITONITIS; Pyogenic Arthritis; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
DAPTOMYCIN	500MG/VIAL	powder · intravenous	TEVA PHARMS USA	Prescription	25 Mar 2016
DAPTOMYCIN	500MG/VIAL	powder · intravenous	XELLIA PHARMS APS	Prescription	15 Jun 2016
DAPTOMYCIN	350MG/VIAL	powder · intravenous	SAGENT PHARMS INC	Prescription	12 Sep 2017
DAPTOMYCIN	350MG/VIAL	powder · intravenous	HIKMA PHARMS	Prescription	20 Oct 2017
DAPTOMYCIN	500MG/VIAL	powder · intravenous	FRESENIUS KABI USA	Prescription	11 Apr 2018
DAPTOMYCIN	500MG/VIAL	powder · intravenous	MYLAN LABS LTD	Prescription	5 Jun 2018
DAPTOMYCIN	500MG/VIAL	powder · intravenous	DR REDDYS	Prescription	1 May 2019
DAPTOMYCIN	500MG/VIAL	powder · intravenous	ACCORD HLTHCARE	Prescription	24 Jun 2019
DAPTOMYCIN	500MG/VIAL	powder · intravenous	BE PHARMS	Prescription	26 Jun 2019
DAPTOMYCIN	350MG/VIAL	powder · intravenous	ACCORD HLTHCARE	Prescription	12 Jul 2019
DAPTOMYCIN	500MG/VIAL	powder · intravenous	SAGENT PHARMS INC	Prescription	15 Nov 2019
DAPTOMYCIN	350MG/VIAL	powder · intravenous	BE PHARMS	Prescription	20 Aug 2020
DAPTOMYCIN	350MG/VIAL	powder · intravenous	DR REDDYS	Prescription	31 Aug 2020
DAPTOMYCIN	500MG/VIAL	powder · intravenous	HISUN PHARM HANGZHOU	Prescription	21 Apr 2021
DAPTOMYCIN	350MG/VIAL; 500MG/VIAL	powder · intravenous	HOSPIRA	Prescription	21 Jun 2021
DAPTOMYCIN	500MG/VIAL	powder · intravenous	MEITHEAL	Prescription	29 Jun 2021
DAPTOMYCIN	350MG/VIAL	powder · intravenous	MEITHEAL	Prescription	29 Jun 2021
DAPTOMYCIN	500MG/VIAL	powder · intravenous	QILU PHARM HAINAN	Prescription	24 Aug 2021
DAPTOMYCIN	500MG/VIAL	powder · intravenous	EUGIA PHARMA	Prescription	2 Sep 2021
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML); 500MG/50ML (10MG/ML); 700MG/100ML (7MG/ML); 1GM/100ML (10MG/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Prescription	25 Jan 2022
DAPTOMYCIN	500MG/VIAL	powder · intravenous	HAINAN POLY PHARM	Prescription	18 Aug 2022
DAPTOMYCIN	500MG/VIAL	powder · intravenous	ASPIRO	Prescription	23 Sep 2022
DAPTOMYCIN	350MG/VIAL	powder · intravenous	ASPIRO	Prescription	23 Dec 2022
DAPTOMYCIN	350MG/VIAL; 500MG/VIAL	powder · intravenous	HIKMA PHARMS	Prescription	30 Jan 2023
DAPTOMYCIN	500MG/VIAL	powder · intravenous	MYLAN	Prescription	7 Aug 2023

10 more — full table

EMA European Union — centrally authorised medicines

Cubicin · Authorised · authorised 19 Jan 2006 · ATC J01XX09

Therapeutic indication (EMA)

Cubicin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Daptomycin Hospira Pfizer Europe MA EEIG · Authorised · authorised 22 Mar 2017 · ATC J01XX09

Therapeutic indication (EMA)

Daptomycin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DAPTOMYCIN FOR INJECTION	02490463	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
DAPTOMYCIN FOR INJECTION	02490838	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
DAPTOMYCIN FOR INJECTION RF	02541920	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DAPTOMYCIN 500 MG VIAL	$23.79838	per EA	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.

Safety signals and safety-related labeling changes

US FDA 12 May 2025 CUBICIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Apr 2025 DAPTOMYCIN — 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 30 Apr 2025 DAPTOMYCIN — 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 30 Apr 2025 DAPTOMYCIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Apr 2025 DAPTOMYCIN — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 30 Apr 2025 DAPZURA RT — safety-related labeling change
Labeling sections changed: Adverse Reactions
EMA PRAC 10 Sep 2015 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Daptomycin: risk of eosinophilic pneumonia
If eosinophilic pneumonia is suspected, daptomycin should be discontinued immediately and if appropriate the patient treated with corticosteroids.

All safety entries for daptomycin →

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.