Quick answers
- What is Folotyn?
- Folotyn is a brand name of Pralatrexate, a prescription medicine. The FDA NDC Directory lists 2 Folotyn products in 2 strengths and forms.
- Who makes Folotyn?
- Acrotech Biopharma holds the FDA application for Folotyn (NDA022468, approved September 24, 2009).
- Is there a generic or store brand of Folotyn?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Folotyn product, 4 of them generic. Ask your pharmacist whether one is right for you.
- Has Folotyn been recalled?
- No recall linked to Folotyn products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Folotyn is
Each Folotyn product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Pralatrexate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pralatrexate 20 mg/mL injection (intravenous) | Folotyn | 2 products, 2 companies | — |
| pralatrexate 40 mg/2 mL injection (intravenous) | Folotyn | 2 products, 2 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Pralatrexate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022468 | Acrotech Biopharma | September 24, 2009 | 2 |
Companies that list Folotyn
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Folotyn products.
- Acrotech Biopharma Inc2 products
Recalls
No recall linked to Folotyn products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.