Folotyn

Product manufactured by Acrotech Biopharma Llc

Application Nr Approved Date Route Status External Links
NDA022468 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Folotyn 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). Folotyn 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 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pralatrexate PRALATREXATE ZINC1536109

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