Application Nr Approved Date Route Status External Links
ANDA077496 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Mitoxantrone Injection, Usp Is Indicated For Reducing Neurologic Disability And/or The Frequency Of Clinical Relapses In Patients With Secondary (Chronic) Progressive, Progressive Relapsing, Or Worsening Relapsing-Remitting Multiple Sclerosis (I.e., Patients Whose Neurologic Status Is Significantly Abnormal Between Relapses). Mitoxantrone Injection, Usp Is Not Indicated In The Treatment Of Patients With Primary Progressive Multiple Sclerosis. The Clinical Patterns Of Multiple Sclerosis In The Studies Were Characterized As Follows: Secondary Progressive And Progressive Relapsing Disease Were Characterized By Gradual Increasing Disability With Or Without Superimposed Clinical Relapses, And Worsening Relapsing-Remitting Disease Was Characterized By Clinical Relapses Resulting In A Step-Wise Worsening Of Disability. Mitoxantrone Injection, Usp In Combination With Corticosteroids Is Indicated As Initial Chemotherapy For The Treatment Of Patients With Pain Related To Advanced Hormone-Refractory Prostate Cancer. Mitoxantrone Injection, Usp In Combination With Other Approved Drug(S) Is Indicated In The Initial Therapy Of Acute Nonlymphocytic Leukemia (Anll) In Adults. This Category Includes Myelogenous, Promyelocytic, Monocytic, And Erythroid Acute Leukemias.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Mitoxantrone Hydrochloride MITOXANTRONE HYDROCHLORIDE ZINC3794794

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