Quick answers
- What is Pralatrexate used for?
- The FDA-approved label (Pralatrexate, Fresenius Kabi USA, LLC, November 15, 2022) says: “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 […]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pralatrexate have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pralatrexate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pralatrexate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pralatrexate?
- 3 companies list prescription products of Pralatrexate in the FDA NDC Directory, including Dr. Reddy's Laboratories Inc., Fresenius Kabi USA, LLC and Acrotech Biopharma Inc.
What Pralatrexate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 […]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). …
— FDA label: Pralatrexate, Fresenius Kabi USA, LLC, effective November 15, 2022. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Folotyn |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Dr. Reddy's Laboratories Inc.2 products
- Fresenius Kabi USA, LLC2 products
- Acrotech Biopharma Inc2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022468 FOLOTYN | Acrotech Biopharma | September 24, 2009 | 10, latest October 20, 2020 2020: Labeling · 2020: Labeling · 2016: Labeling |
Generic approvals (1)
- ANDA206183DR Reddys · March 10, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1796419, 1796424 |
|---|---|
| SPL set ID of the quoted label | a5daa583-4965-4564-ad87-41ffe6c08a11 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA022468, 1 ANDA |
| Active ingredients (FDA) | PRALATREXATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pralatrexate, Fresenius Kabi USA, LLC, effective November 15, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →