FDA — authorised 24 September 2009
- Application: NDA022468
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: FOLOTYN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Pralatrexate injection in United States
FDA authorised Pralatrexate injection on 24 September 2009 · 34 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 23 April 2025 – 23 April 2026
- Total reports: 34
Most-reported reactions
- Stomatitis — 7 reports (20.59%)
- Platelet Count Decreased — 6 reports (17.65%)
- Malignant Neoplasm Progression — 4 reports (11.76%)
- Anaemia — 3 reports (8.82%)
- Lymphopenia — 3 reports (8.82%)
- Mucosal Inflammation — 3 reports (8.82%)
- Constipation — 2 reports (5.88%)
- Death — 2 reports (5.88%)
- Diarrhoea — 2 reports (5.88%)
- Fall — 2 reports (5.88%)
Other Oncology approved in United States
Frequently asked questions
Is Pralatrexate injection approved in United States?
Yes. FDA authorised it on 24 September 2009.
Who is the marketing authorisation holder for Pralatrexate injection in United States?
ACROTECH BIOPHARMA holds the US marketing authorisation.