Application Nr Approved Date Route Status External Links
NDA207793 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Onivyde ® Is Indicated, In Combination With Fluorouracil And Leucovorin, For The Treatment Of Patients With Metastatic Adenocarcinoma Of The Pancreas After Disease Progression Following Gemcitabine-Based Therapy. Limitation Of Use: Onivyde Is Not Indicated As A Single Agent For The Treatment Of Patients With Metastatic Adenocarcinoma Of The Pancreas [See Clinical Studies (14) ] . Onivyde Is A Topoisomerase Inhibitor Indicated, In Combination With Fluorouracil And Leucovorin, For The Treatment Of Patients With Metastatic Adenocarcinoma Of The Pancreas After Disease Progression Following Gemcitabine-Based Therapy. ( 1 ) Limitation Of Use: Onivyde Is Not Indicated As A Single Agent For The Treatment Of Patients With Metastatic Adenocarcinoma Of The Pancreas. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE ZINC1612996

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