Navigation Links
Sanofi-Aventis Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri(R)) Submission
Date:9/21/2009

BRIDGEWATER, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin (Ciltyri(R)). Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.

Sanofi-aventis is currently reviewing the content of the complete response letter, in which the FDA has requested additional information regarding benefit-risk. The company will contact the FDA in the coming days to request a meeting to discuss what steps and data would be needed for approval.

About eplivanserin (Ciltyri(R))

Eplivanserin, discovered and developed by sanofi-aventis, is a serotonin type 2 A receptor antagonist, and unlike benzodiazepine-receptor agonists (BzRAs), has no affinity for GABA receptors. It has been studied in a clinical development program including nearly 3,000 patients.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, visit: www.sanofi-aventis.us or www.sanofi-aventis.com

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

US.EPL.09.07.003

    U.S. Media Contact:
    Susan Brooks
    (908)981-6566
    susan.brooks@sanofi-aventis.com


'/>"/>
SOURCE sanofi-aventis
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Sanofi-Aventis Recognized for Workplace Efforts to Prevent Cancer
2. Beacon Equity Researches: Sanofi-Aventis, Amazon, Yahoo, Johnson & Johnson, Novavax and NexMed
3. Sanofi-aventis Announces Good First-quarter 2009 Performance
4. Sanofi-Aventis and Roche/Chugais Drugs Will Dominate the Indian Colorectal Cancer Drug Market Through 2013
5. Sanofi-aventis Affirms Its Commitment to Partnering with Local Communities to Improve Hispanic and African American Health
6. Apidra(R) SoloSTAR(R), the Easy-to-Use Insulin Delivery Device from sanofi-aventis, Now Available in the United States
7. Paul Chew Appointed to sanofi-aventis U.S. Chief Science Officer/Chief Medical Officer
8. Sanofi-aventis Partners with the Hispanic Community in Miami to Increase Health Awareness, Access to Resources and Help Improve Patient Care
9. Sanofi-aventis Partners with the Hispanic Community in San Antonio to Increase Health Awareness, Access to Resources and Help Improve Patient Care
10. Sanofi-aventis Delivers 2008 Results Above Guidance
11. Sanofi-aventis Partners with the Hispanic Community in Bronx to Increase Health Awareness, Access to Resources and Help Improve Patient Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... ... March 23, 2017 , ... ... MEDDEV 2.7/1 Rev. 4 Guidance, **An FDAnews Webinar**, April 4, 2017 — ... the new EU MDR language change the way manufacturers approach CERs? , ...
(Date:3/23/2017)... Marina del Rey, CA (PRWEB) , ... March ... ... version of its customizable coding audit software solution, iCode Assurance, at HCCA’s 21st ... iCode Assurance optimizes and accelerates the coding audit process for all medical chart ...
(Date:3/23/2017)... ... March 23, 2017 , ... “Beyond and Back”: a true-life testimony of tragedy ... of published author Bonetta Rose, a wife, mother and grandmother committed to sharing her ... Faith Publishing, Bonetta Rose‘s new book presents actual events in the life of her ...
(Date:3/23/2017)... ... March 23, 2017 , ... “My Journey Through Heaven”: the true-life account of ... profound faith of God’s promise of Heaven for His people. “My Journey Through Heaven” ... with his wife, three children and six grandchildren living and doing for God as ...
(Date:3/23/2017)... ... March 23, 2017 , ... “A Respectful Response To Atheist ... To Atheist Manifesto” is the creation of published author Richard Hostetter, a former ... years. He holds graduate degrees from Kent State University and the University of ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... LONDON , March 23, 2017 ... for its CTX cells in chronic stroke patients, despite not ... its primary outcome measure, the Action Research Arm Test (ARAT). ... progress to a pivotal controlled clinical study in 2017. Beyond ... pigmentosa (RP) trial in 2017 and Phase I data from ...
(Date:3/23/2017)... -- During the "Nudging for Good" ... , My UV Patch, La Roche-Posay,s digital breakthrough ... ones, was awarded the Diamond Award by the ... "Nudging for Good" Award aims to honor brands ... to change behaviour and adopt a healthier and/or ...
(Date:3/23/2017)... The Board of Directors of NeuroVive Pharmaceutical ... which is to take place on Thursday, April 27, 2017, at ... Sweden . ... Please see the attached notification, which is being announced within short ... Pharmaceutical AB (Publ) The Board Of Directors About NeuroViveNeuroVive ...
Breaking Medicine Technology: