Beleodaq

Product manufactured by Acrotech Biopharma Llc

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 Adult 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 Adult 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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