Is Caspofungin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 12 valid registrations of Caspofungin, including AFUNDAS-L 50 MG (50 mg, Powder for concentrate for solution for infusion, SAR 675.30); AFUNDAS-L 70 MG (70 mg, Powder for concentrate for solution for infusion, SAR 819.55); CANCIDAS 50 MG VIAL (50 mg, Powder for concentrate for solution for infusion, SAR 987.65); CANCIDAS 70 MG VIAL (70 mg, Powder for concentrate for solution for infusion, SAR 987.65); CANGIN (70 mg, Powder for concentrate for solution for infusion, SAR 663.85).

Is Caspofungin approved by the US FDA?

Drugs@FDA lists 9 application product lines for Caspofungin, including CASPOFUNGIN ACETATE (Prescription); CASPOFUNGIN ACETATE (Prescription); CASPOFUNGIN ACETATE (Prescription); CASPOFUNGIN ACETATE (Prescription); CANCIDAS (Discontinued).

Is Caspofungin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Caspofungin: Cancidas (previously Caspofungin MSD).

Is Caspofungin on the WHO Model List of Essential Medicines?

Yes — 6.3. Antifungal medicines (complementary list): Therapeutic equivalent to micafungin for Systemic or invasive candidosis.

Are there safety signals or safety updates for Caspofungin?

US FDA: 2 entries (latest 2021-04-01).

Active substance

Caspofungin

SFDA 18
US FDA 9
EMA 2
Health Canada 5
WHO EML 1
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
AFUNDAS-L 50 MG	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 675.30	Generic · Prescription	Sandoz IIac San	Valid
AFUNDAS-L 70 MG	70 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 819.55	Generic · Prescription	Sandoz IIac San	Valid
CANCIDAS 50 MG VIAL	50 mg	Powder for concentrate for solution for infusion · Parenteral use	1 Vial	SAR 987.65	NCE · Prescription	MERCK SHARP & DOHME	Valid
CANCIDAS 70 MG VIAL	70 mg	Powder for concentrate for solution for infusion · Parenteral use	1 Vial	SAR 987.65	NCE · Prescription	MERCK SHARP & DOHME	Valid
CANGIN	70 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 663.85	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CANGIN	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 518.15	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
COPSFIN 50MG VIAL	50 mg	Powder for solution for injection/infusion · Parenteral use	1 Vial	SAR 518.15	Generic · Prescription	Boston Oncology Arabia	Valid
COPSFIN 70MG VIAL	70 mg	Powder for solution for injection/infusion · Parenteral use	1 Vial	SAR 663.85	Generic · Prescription	Boston Oncology Arabia	Valid
Capgin	70 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 648.80	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Capgin	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 506.40	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Kanvasiv	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 518.15	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Kanvasiv	70 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 663.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
FUNGISKA 50 mg Vial	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 639.70	Generic · Prescription	SPIMACO ADDWAEIH	Suspended
FUNGISKA 70 mg Vial	70 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 819.55	Generic · Prescription	SPIMACO ADDWAEIH	Suspended
CANCIDAS 50 MG VIAL	50 mg	Powder for concentrate for solution for infusion · Parenteral use	1 Vial	SAR 2293.65	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
CANCIDAS 70 MG VIAL	70 mg	Powder for concentrate for solution for infusion · Parenteral use	1 Vial	SAR 2917.25	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
CASPOFUNGIN 50MG VIAL	50 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 575.75	Generic · Prescription	Macarthys Laboratories Ltd t/a Martindale Pharma	Withdrawn by MAH · Not Marketed
CASPOFUNGIN 70MG VIAL	70 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 737.60	Generic · Prescription	Macarthys Laboratories Ltd t/a Martindale Pharma	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; ENDOCARDITIS; ESOPHAGEAL CANDIDIASIS; INTRA-ABDOMINAL INFECTIONS; Invasive Candidiasis and Candidemia; PERITONITIS, TERTIARY PERITONITIS, POST-OPERATIVE PERITONITIS, PERITONEAL DIALYSIS RELATED PERITONITIS; Pyogenic Arthritis; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	FRESENIUS KABI USA	Prescription	30 Dec 2016
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	GLAND	Prescription	29 Sep 2017
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	AREVA PHARMS	Prescription	1 Oct 2021
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	HANGZHOU ZHONGMEI	Prescription	18 Jul 2025
CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	powder · intravenous	MERCK	Discontinued	26 Jan 2001
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	PHARMOBEDIENT	Discontinued	29 Sep 2017
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	HENGRUI PHARMA	Discontinued	28 Jun 2018
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	XELLIA PHARMS APS	Discontinued	2 Jul 2018
CASPOFUNGIN ACETATE	50MG/VIAL; 70MG/VIAL	powder · intravenous	CIPLA	Discontinued	12 Jul 2018

EMA European Union — centrally authorised medicines

Cancidas (previously Caspofungin MSD) · Authorised · authorised 23 Oct 2001 · ATC J02AX04

Therapeutic indication (EMA)

Treatment of invasive candidiasis in adult or paediatric patients; treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and / or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy; empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.

Caspofungin Accord Accord Healthcare S.L.U. · Expired · authorised 11 Feb 2016 · ATC J02AX04

Therapeutic indication (EMA)

Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CANCIDAS	02244266	70 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	MERCK CANADA INC
CASPOFUNGIN FOR INJECTION	02460947	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
CASPOFUNGIN FOR INJECTION	02460955	70 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
CASPOFUNGIN FOR INJECTION	02486989	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
CASPOFUNGIN FOR INJECTION	02486997	70 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD

WHO WHO Model List of Essential Medicines (2025)

6.3. Antifungal medicines · complementary
Therapeutic equivalent to micafungin for Systemic or invasive candidosis

Safety signals and safety-related labeling changes

US FDA 1 Apr 2021 CASPOFUNGIN ACETATE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 Feb 2019 CANCIDAS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for caspofungin →

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.