Prescription medicine

Pralatrexate Brand names: Folotyn

Pralatrexate (Folotyn) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed

Check it at the source: the pralatrexate FDA label on DailyMed (effective November 15, 2022, Fresenius Kabi USA, LLC); the NDA 22468 record on Drugs@FDA; every pralatrexate label on DailyMed.

Highlights of the record

FDA label of November 15, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Forms and strengths

20 mg/ml
40 mg/2ml

Injection.

On the market

Earliest approval on file: September 24, 2009 Folotyn, Acrotech Biopharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 1 first March 10, 2025; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 3 of which 1 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 205 through July 30, 2026

What is pralatrexate used for?

From the label: indications and usage
Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. […]

Conditions named in the indications of pralatrexate's FDA labels, with every medicine labeled for each:

Leukemia, lymphoma and myeloma

FDA pharmacologic class: Folate Analog Metabolic Inhibitor.

Source: FDA drug label (Pralatrexate), NDA022468 (Acrotech Biopharma), as published by Fresenius Kabi USA, LLC, effective November 15, 2022 (SPL set a5daa583-4965-4564-ad87-41ffe6c08a11), via openFDA; the full label on DailyMed

Is there a generic for pralatrexate (Folotyn)?

The FDA approved the first generic pralatrexate on March 10, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists pralatrexate from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

2009 earliest approval on file
2025 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the pralatrexate label say about other medicines?

The pralatrexate label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name pralatrexate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Probenecid	drug interactions	DRUG INTERACTIONS Avoid coadministration with probenecid or nonsteroidal anti-inflammatory drugs.

Other labels that name pralatrexate

Sepiapterin

Check pralatrexate against other medicines

What do FAERS reports show for pralatrexate?

The FDA Adverse Event Reporting System holds 205 reports that list pralatrexate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 37 are coded as a death and 83 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)34
Disease Progression (a use or a product term, not a reaction)27
Malignant Neoplasm Progression27
Pyrexia (named in the label)21
Anaemia (named in the label)18
Mucosal Inflammation (named in the label)18
Neutropenia (named in the label)18
Febrile Neutropenia (named in the label)17

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as pralatrexate?

36 other medicines are given the same way (intravenous) and in the same FDA class as pralatrexate or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Cyclophosphamide	Leukemia, lymphoma and myeloma	15 labelers	n/a	No current entry
Doxorubicin	Leukemia, lymphoma and myeloma	16 labelers	n/a	No current entry
Bortezomib	Leukemia, lymphoma and myeloma	22 labelers	n/a	No current entry
Arsenic trioxide	Leukemia, lymphoma and myeloma	16 labelers	n/a	A presentation being discontinued
Bendamustine	Leukemia, lymphoma and myeloma	4 labelers	n/a	A presentation being discontinued
Nelarabine	Leukemia, lymphoma and myeloma	12 labelers	n/a	No current entry
Idarubicin	Leukemia, lymphoma and myeloma	2 labelers	n/a	No current entry
Clofarabine	Leukemia, lymphoma and myeloma	9 labelers	n/a	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Other folate analog metabolic inhibitors: the pharmacologic class, with prices and generics
Pralatrexate side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other