Is Tigecycline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Tigecycline, including Cabitac (50 mg, Powder for solution for infusion, SAR 1028.45); TEGECEN (50 mg, Powder for solution for infusion, SAR 870.55); TYGACIL 50MG LYOP. POW. FOR I.V.INFUSION (50 mg, Powder for solution for infusion, SAR 1285.50); Tigebax (50 mg, Powder for infusion, SAR 111.40); Tigecycline BOS (50 mg, Powder for solution for infusion, SAR 119.95).

Is Tigecycline approved by the US FDA?

Drugs@FDA lists 9 application product lines for Tigecycline, including TYGACIL (Prescription); TIGECYCLINE (Prescription); TIGECYCLINE (Prescription); TIGECYCLINE (Prescription); TIGECYCLINE (Prescription).

Is Tigecycline authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Tigecycline: Tygacil, Tigecycline Accord.

Are there safety signals or safety updates for Tigecycline?

EMA PRAC: 4 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2025-03-31).

Active substance

Tigecycline

SFDA 8
US FDA 9
EMA 3
Health Canada 2
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cabitac	50 mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 1028.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
TEGECEN	50 mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 870.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
TYGACIL 50MG LYOP. POW. FOR I.V.INFUSION	50 mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 1285.50	NCE · Prescription	Pfizer Europe MA EEIG	Valid
Tigebax	50 mg	Powder for infusion · Intravenous use	1 Vial	SAR 111.40	Generic · Prescription	Glenmark Pharmaceuticals Limited	Valid
Tigecycline BOS	50 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 119.95	Generic · Prescription	Boston Oncology Arabia	Valid
Tugatev	50 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 72.00	Generic · Prescription	Med City Pharma	Valid
Vantag	50 mg	Powder for solution for infusion · Intramuscular and intravenous use	10 Vial	SAR 1028.45	Generic · Prescription	Advanced Pharmaceutical Industries	Valid
TYGACIL 50MG LYOP. POW. FOR I.V.INFUSION	50 mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 2151.25	NCE · Prescription	WYETH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); INTRA-ABDOMINAL INFECTIONS; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
TYGACIL	50MG/VIAL	powder · intravenous	PF PRISM CV	Prescription	15 Jun 2005
TIGECYCLINE	50MG/VIAL	powder · intravenous	SANDOZ	Prescription	27 May 2015
TIGECYCLINE	50MG/VIAL	powder · intravenous	AMNEAL	Prescription	2 Aug 2018
TIGECYCLINE	50MG/VIAL	powder · intravenous	APOTEX	Prescription	21 Dec 2018
TIGECYCLINE	50MG/VIAL	powder · intravenous	EUGIA PHARMA	Prescription	11 Jun 2019
TIGECYCLINE	50MG/VIAL	powder · intravenous	MEITHEAL	Prescription	13 May 2021
TIGECYCLINE	50MG/VIAL	powder · intravenous	FRESENIUS KABI USA	Discontinued	1 Dec 2016
TIGECYCLINE	50MG/VIAL	powder · intravenous	ACCORD HLTHCARE INC	Discontinued	18 Jan 2018
TIGECYCLINE	50MG/VIAL	powder · intravenous	XELLIA PHARMS APS	Discontinued	18 Oct 2019

EMA European Union — centrally authorised medicines

Tygacil Pfizer Europe MA EEIG · Authorised · authorised 24 Apr 2006 · ATC J01AA12

Therapeutic indication (EMA)

Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections Complicated intra-abdominal infections (cIAI) Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.

Tigecycline Accord Accord Healthcare S.L.U. · Authorised · authorised 17 Apr 2020 · ATC J01AA12

Therapeutic indication (EMA)

Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4) Complicated intra-abdominal infections (cIAI) Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Tigecycline Accord Accord Healthcare Ltd · Application withdrawn · ATC J01AA12

Therapeutic indication (EMA)

Treatment of: - complicated skin and soft tissue infections, excluding diabetic foot infections - complicated intra-abdominal infections Tygacil should be used only in situations where it is known or suspected that other alternatives are not suitable

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TIGECYCLINE	02409356	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	APOTEX INC
TYGACIL	02285401	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 31 Mar 2025 TYGACIL — 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 31 Mar 2025 TIGECYCLINE — 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 31 Mar 2025 TIGECYCLINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 31 Mar 2025 TIGECYCLINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 31 Oct 2019 PRAC signal: Bradycardia
Action for MAH: update of the product information: No
EMA PRAC 16 May 2019 PRAC signal: Bradycardia
Action for MAH: update of the product information: No
EMA PRAC 17 Mar 2016 PRAC signal: Hypofibrinogenaemia
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2015 PRAC signal: Hypofibrinogenaemia
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Tigecycline (Tygacil▼): increased mortality in clinical trials
Use only when other antibiotics are unsuitable

All safety entries for tigecycline →

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.