Application Nr Approved Date Route Status External Links
NDA205353 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Farydak, A Histone Deacetylase Inhibitor, In Combination With Bortezomib And Dexamethasone, Is Indicated For The Treatment Of Patients With Multiple Myeloma Who Have Received At Least 2 Prior Regimens, Including Bortezomib And An Immunomodulatory Agent. This Indication Is Approved Under Accelerated Approval Based On Progression Free Survival [see Clinical Studies (14.1)] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. Farydak, A Histone Deacetylase Inhibitor, In Combination With Bortezomib And Dexamethasone, Is Indicated For The Treatment Of Patients With Multiple Myeloma Who Have Received At Least 2 Prior Regimens, Including Bortezomib And An Immunomodulatory Agent. This Indication Is Approved Under Accelerated Approval Based On Progression Free Survival. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Panobinostat Lactate

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