Navigation Links
FDA Approves Five-Day Dosing Regimen for Dacogen(R) (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
Date:3/11/2010

WOODCLIFF LAKE, N.J., March 11 /PRNewswire-FirstCall/ -- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

The new outpatient dosing option provides physicians and patients with the flexibility of a dosing regimen with a reduced infusion time. Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new regimen will be administered at a dose of 20 mg/m2 continuous intravenous (IV) infusion over one hour repeated daily for five days per cycle.  The cycle is repeated every four weeks.

The previously approved Dacogen three-day regimen is administered in an in-patient setting at a dose of 15 mg/m2 continuous IV infusion over three hours repeated every eight hours for three days per cycle and repeated every six weeks.

Three open-label, single-arm, multicenter studies were conducted to evaluate the safety and efficacy of Dacogen in MDS patients with any of the French-American-British (FAB) subtypes. In one study, 99 patients with International Prognostic Scoring System (IPSS) Intermediat
'/>"/>

SOURCE Eisai Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. European Union Approves Corn Stack with Herculex RW and Roundup Ready 2 Traits for Food, Feed, Import and Processing
2. EU Committee Approves New Food Applications for Marteks lifesDHA(TM)
3. EU Committee Approves New Food Applications for Martek's life'sDHA™
4. Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Facial Filler
5. FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
6. FDA Approves Boston Scientifics Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System
7. Arpida Annual General Meeting of Shareholders Approves All Board Proposals
8. Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
9. FDA Approves Label Change for Non-Invasive Fibroid Treatment
10. FDA Approves SyntheMeds REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
11. FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... , July 31, 2015 In today,s ... that help them drive positive health outcomes, improve ... source of patient care in their communities. At ... tradeshow and conference, AmerisourceBergen announced a new set ... Services Administration Organization and help independent pharmacies endure ...
(Date:7/31/2015)... ... July 31, 2015 , ... Global ... and premium industry insights on the global resorcinol industry. The report highlights the ... of vivid market scenarios and analysis of primary and secondary inputs from the ...
(Date:7/31/2015)... , July 31, 2015 China Cord Blood ... China,s leading provider of cord blood collection, ... storage services, today announced that the Company has filed ... Securities and Exchange Commission. The filed Form 20-F includes ... 31, 2015. The Form 20-F can be accessed by ...
(Date:7/31/2015)... ... July 31, 2015 , ... R-Biopharm is proud ... partially hydrolyzed gluten in foods, has been accepted by AOAC International as Official ... Gluten in Fermented Cereal-Based Products by R5 Competitive ELISA,” based on a specific ...
Breaking Biology Technology:AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 2AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 3Resorcinol Market to Grow at 6% CAGR to 2019 Says New Research Report at ReportsnReports.com 2Resorcinol Market to Grow at 6% CAGR to 2019 Says New Research Report at ReportsnReports.com 3Resorcinol Market to Grow at 6% CAGR to 2019 Says New Research Report at ReportsnReports.com 4China Cord Blood Corporation Files Its Annual Report on Form 20-F 2RIDASCREEN® Competitve Gliadin Receives AOAC Official First Action Status 2
... Everyone wants to design the dsRNA that , ... length correlate with silencing efficiency? Ambion scientists , ... dsRNA of different sizes and directed , ... (Figure 1A), were prepared using the MEGAscript RNAi Kit ...
... Large scale gene expression studies , ... purify high quality RNA from a large number of samples. Although the , ... dsRNA production and , clean up, ... format. Thus for high-throughput applications, we recommend , ...
... , ... heterogenous samples is a major challenge in studying gene , ... microdissection (LCM), developed in a collaborative ... and Arcturus, Inc. specifically to isolate , ...
Cached Biology Technology:RNAi: Size Does Matter 2RNAi for High Throughput Analysis 2RNA from LCM Samples 2RNA from LCM Samples 3
(Date:7/31/2015)... Kina, 31. juli 2015 Den 10. internationale ... af BGI fra den 22. - 25. oktober i ... fejrer sin 10-års fødselsdag i år. Siden starten i ... årlige møder på ,omik,-feltet, og er en af de ... ICG-10 fokuserer på nylige gennembrud og fremskridt inden ...
(Date:7/31/2015)... China , 31 de julio de 2015 /PRNewswire/ ... Genómica (ICG-10,  www.icg-10.org ) del 22 al 25 de ... . La conferencia celebra su décimo aniversario ... ha convertido en una de las reuniones anuales más ... y es una de las conferencias científicas más dinámicas, ...
(Date:7/31/2015)... 31 de julho de 2015 A 10 ... ) será realizada pela BGI de 22-25 de outubro de ... A conferência está celebrando seu 10 o. ... ICG se tornou uma das reuniões mais influentes do ... científicos mais dinâmicos, entusiastas e prazerosos. ...
Breaking Biology News(10 mins):Den 10. internationale konference om Genomics (ICG-10) åbner i oktober 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 3A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 2A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 3
... The destructive cellular pathways activated in Alzheimer,s ... say researchers from Georgetown University Medical Center (GUMC). ... might successfully target both conditions. In an ... Conference on Alzheimer,s Disease, the scientists will show ...
... The Federal Bureau of Investigation (FBI) has awarded ... $47 million contract to continue managing the FBI Criminal ... program. The contract covers the conversion of paper fingerprint, ... for the FBI. , , Records processed ...
... PARK, Calif., June 29 Kornberg Associates | Architects ( ... University to design a new Cognitive & Neurobiological Imaging ... The firm has worked with Stanford University ... 30 years, one of which is the two-story, 32,000 square-foot ...
Cached Biology News:Alzheimer's disease drug treats traumatic brain injury, report GUMC researchers 2Federal Bureau of Investigation Awards Lockheed Martin Biometric Card Scanning Service Contract 2Kornberg Associates Architects Selected to Develop Design for New Stanford University Imaging Center 2
Poly A Polymerase catalyzes the addition of AMP to the 3' hydroxyl terminus of RNA. Poly A Polymerase can add poly(C) and poly(U) to RNA but does so with much-reduced efficiency....
... Preparation contains a unique β-agarose digesting enzyme ... of intact DNA and RNA from low ... in TAE, TBE, MOPS, or phosphate buffers. ... the TAE, TBE, MOPS, and phosphate electrophoresis ...
Recombinant Cat Interferon Alpha Activity: 2.7 x 10 7 u/mg...
... The RapidStak is a fast ... its class. Its high capacity ... and more confident walk away time ... and ease of set-up make for ...
Biology Products: