Is Pralatrexate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Pralatrexate, including FOLOTYN 20MG/ML SOLUTION FOR INFUSION (20 mg/ml, Solution for infusion, SAR 15091.70).

Is Pralatrexate approved by the US FDA?

Drugs@FDA lists 2 application product lines for Pralatrexate, including FOLOTYN (Prescription); PRALATREXATE (Prescription).

Is Pralatrexate authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Pralatrexate.

Are there safety signals or safety updates for Pralatrexate?

US FDA: 1 entry (latest 2020-05-14).

Active substance

Pralatrexate

SFDA 1
US FDA 2
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FOLOTYN 20MG/ML SOLUTION FOR INFUSION	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 15091.70	NCE · Prescription	MUNDIPHARMA MEDICAL COMPANY	Valid

Indications — CHI Daman Drug Formulary

T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
FOLOTYN	20MG/ML (20MG/ML); 40MG/2ML (20MG/ML)	solution · intravenous	ACROTECH BIOPHARMA	Prescription	24 Sep 2009
PRALATREXATE	20MG/ML (20MG/ML); 40MG/2ML (20MG/ML)	solution · intravenous	DR REDDYS	Prescription	10 Mar 2025

EMA European Union — centrally authorised medicines

Folotyn Allos Therapeutics Ltd · Refused · ATC L01BA05

Therapeutic indication (EMA)

treatment of peripheral T-cell lymphoma

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FOLOTYN	02481820	20 MG / ML	SOLUTION · INTRAVENOUS	SERVIER CANADA INC

Safety signals and safety-related labeling changes

US FDA 14 May 2020 FOLOTYN — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for pralatrexate →

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.