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FDA Approval Summary | 合法藥品大搜索

FDA Approval Summary

由YLKasamon著作·2018·被引用21次—MidostaurinistheonlyU.S.FoodandDrugAdministration‐approvedtherapyforpatientswithsystemicmastocytosiswithassociatedhematologicalneoplasmand​ ...

 FDA Approval Summary

Oncologist. 2018 Dec; 23(12): 1511–1519.

,*a ,a ,a ,a ,a ,a ,a ,a ,a ,a,b and a,b[1] Yvette L. Kasamon

a Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Chia‐Wen Ko

a Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Sriram Subramaniam

a Center for Drug Evaluation and Research, U.S. Food and Drug Administra...

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Midostaurin | 合法藥品大搜索
2017年4月28日 — FDA also approved midostaurin for the treatment of adults with aggressive systemic mastocytosis (SM), SM with associated hematological ... Read More
FDA approves new combination treatment for acute myeloid ... | 合法藥品大搜索
2017年4月28日 — The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute ... Read More
RYDAPT (midostaurin) | 合法藥品大搜索
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and ... Read More
Label (PDF) | 合法藥品大搜索
Information on FDA-approved tests for the detection of FLT3 mutation in AML is ... RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to ... Read More
Draft Guidance on Midostaurin Active Ingredient | 合法藥品大搜索
This draft guidance, when finalized, will represent the current thinking of the Food and Drug. Administration (FDA, or the Agency) on this topic. It does not ... Read More
RYDAPT (midostaurin) Capsules | 合法藥品大搜索
Date created: January 5, 2017. Back to Top Drugs@FDA. Vision impaired people having problems accessing certain pages of a PDF file may call (301) ... Read More
RYDAPT (midostaurin) capsules | 合法藥品大搜索
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and ... Read More
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FDA approval history for Rydapt (midostaurin) used to treat Acute Myeloid Leukemia. Supplied by Novartis. Read More
FDA Approval Summary | 合法藥品大搜索
由 YL Kasamon 著作 · 2018 · 被引用 21 次 — Midostaurin is the only U.S. Food and Drug Administration‐approved therapy for patients with systemic mastocytosis with associated hematological neoplasm and​ ... Read More
FDA Approves RYDAPT® (Midostaurin) | 合法藥品大搜索
On April 28, 2017, the United States Food and Drug Administration (FDA) approved RYDAPT (midostaurin) for the treatment of adult patients with: Newly ... Read More
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