pralatrexate
Drug Details
- Generic Name
- pralatrexate
- Brand Names
- Folotyn
- Application Number
- NDA022468
- Sponsor
- Acrotech Biopharma Inc
- NDC Codes
- 2
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- PRALATREXATE
Indications and Usage
1 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )