dacogen aml approval

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dacogen aml approval
Dacogen (decitabine) FDA Approval History - Drugs.com, FDA approves venetoclax in combination for AML in adults, DACOGEN® Approved In the European Union for the Treatment , U.S. FDA Approves Dacogen (Decitabine) For Injection, Decitabine Approved for Elderly AML in Europe - Medscape, FDA rejects Eisai's Dacogen for AML, looks at epilepsy , , , .
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 1 May 2019), Cerner Multum™ (updated 2 May 2019), Wolters Kluwer™ (updated 1 May 2019) and others.. Dacogen (decitabine) is a hypomethylating agent indicated for treatment of patients with myelodysplastic syndromes (MDS), a cancer of the bone marrow. Development History and FDA Approval Process for Dacogen. On November 21, 2018, the Food and Drug Administration granted accelerated approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low .
DACOGEN ® is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 35 countries worldwide including key markets such as the United States, Brazil, China, India, Korea, Russia and Turkey.. with acute myeloid leukemia, chronic myelogenous leukemia, and solid tumors, in addition to developing alternative dosing regimens for patients with MDS." "This approval is a significant milestone for SuperGen.. September 28, 2012 — The European Commission has approved the hypomethylating agent decitabine (Dacogen, Astex/Eisai) for acute myeloid leukemia (AML) in adults 65 years and older, Astex . Dacogen is already approved in the USA for the treatment of patients with myelodysplastic syndromes. Astex Pharmaceuticals licensed the drug to Eisai which in turn sold rights outside of North America to Johnson and Johnson and the latter's Janssen unit submitted a file for Dacogen as a treatment for AML in Europe in May last year.. . .
 
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