Application Nr Approved Date Route Status External Links
NDA206256 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Beleodaq 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 Tumor Response Rate And Duration Of Response [See Clinical Studies ( 14 )]. An Improvement In Survival Or Disease-Related Symptoms Has Not Been Established. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In The Confirmatory Trial. Beleodaq Is A Histone Deacetylase 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 Tumor Response Rate And Duration Of Response. An Improvement In Survival Or Disease-Related Symptoms Has Not Been Established. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In The Confirmatory Trial. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Belinostat BELINOSTAT ZINC3818726

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