Printer Friendly

Eisai Resubmits Supplemental New Drug Application for Aricept, Alzheimers Disease Drug, to FDA.

Tokyo, Japan, Dec 21, 2005 - (JCN) - Eisai has announced that its US subsidiary Eisai Medical Research resubmitted a supplemental new drug application (sNDA) for Aricept, the company's proprietary agent for treating severe Alzheimer's disease, to the US Food and Drug Administration (FDA) as of December 16.

The US subsidiary first submitted the sNDA on August 31, but the FDA turned down the application on the grounds that the application did not conform to the FDA standard. The resubmitted sNDA is expected to be accepted by the FDA within 60 days.

Copyright [c] 2005 Japan Corporate News Network. All rights reserved.
COPYRIGHT 2005 Japan Corporate News Network K.K.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

Article Details
Printer friendly Cite/link Email Feedback
Publication:JCNN News Summaries
Date:Dec 24, 2005
Words:100
Previous Article:Epson Toyocom Announces Smallest-Class VCXO for Mobile Handsets with Support for Terrestrial Digital Broadcasts.
Next Article:Sosei, HRA, and Sandoz/Hexal Australia to Conclude Sublicensing Agreement for "Morning After Pill" SOH-075.


Related Articles
Eisai Announces Strategic Alliance With BioArctic Neuroscience To Develop Immunotherapy For Alzheimer's Disease.
Eisai Files Application Seeking Additional Indication for ARICEPT in US.
Eisai Announces Results of Overseas Clinical Trials of Donepezil in Treating Vascular Dementia.
Asahi Kasei Pharma and Eisai in Sales Promotion Agreement for Eril in China.
Dainippon Sumitomo Pharma and Eisai Sign Licensing Agreement for "Gasmotin", a Gastroprokinetic Agent, for Countries in Asia including ASEAN Members.
Eisai, Nitto Denko to Co-develop Transdermal Formulation of Alzheimer's Disease Agent ARICEPT.
Eisai Files Application Seeking Additional Indication for ARICEPT in Europe.
A prescription for success: finding career opportunities in the pharmaceutical industry.
Eisai Recieves Positive Opinion for Inovelon(R) Marketing Authorization from European Committee for Medicinal Products for Human Use (CHMP).
Eisai Announces Inovelon(R) Receives Marketing Authorization Approval from European Commission.

Terms of use | Privacy policy | Copyright © 2021 Farlex, Inc. | Feedback | For webmasters |