Navigation Links
FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
Date:7/8/2009

can-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups.

Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for two months afterwards. The most commonly occurring adverse reactions with Dacogen include neutropenia (90 percent), thrombocytopenia (89 percent), anemia (82 percent), pyrexia (53 percent), fatigue (48 percent), nausea (42 percent), cough (40 percent), petechiae (39 percent), constipation (35 percent), and diarrhea (34 percent).

Please visit www.dacogen.com for full prescribing information.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.


'/>"/>
SOURCE Eisai Corporation of North America
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related medicine technology :

1. FDA Accepts Arno Therapeutics IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway
2. Food and Drug Administration Accepts Isolagens Biologics License Application for Full Review
3. FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)
4. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
5. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
6. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
7. New Heart Ultrasound Research Reveals Life-Saving Treatment Alternatives and Advancements for Heart Patients
8. Researchers at the Karmanos Cancer Institute in Detroit Discover Feasibility of Chemotherapy Alternative
9. Gallbladder Removal Through Vagina Offers Minimally Invasive Alternative
10. Comprehensive Safety Tests Published on Ruyan(R) Smoking Alternatives
11. Encorium Announces the Initiation of a Strategic Partnership With Prologue Research After the Postponement of Negotiations Regarding Its Planned Acquisition; Strategic Reorganization and Cost Reduction Plan Initiated as Strategic Alternatives are Investig
Post Your Comments:
*Name:
*Comment:
*Email: