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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... PurhealthRX ... CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will ... and providing a CBD form that can be easily incorporated into liquid products, while ...
(Date:10/13/2017)... ... , ... Apple Rehab Shelton Lakes , which specializes in the delivery ... as part of a disaster drill on October 3rd. , Apple Rehab participated with ... Manager, as well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 2017  Caris Life Sciences ® , a leading ... of precision medicine, today announced that St. Jude Medical ... Alliance™ (POA) as its 17 th member. Through ... Crosson Cancer Institute will help develop standards of care ... profiling, making cancer treatment more precise and effective. ...
(Date:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical Services, ... solutions for injectable drug administration, today shared the results ... Adapter for improving the intradermal administration of polio vaccines. ... Vaccination Summit in May 2017 by Dr. Ondrej ... Department, World Health Organization (WHO), and recently published in ...
(Date:10/4/2017)... Oct. 4, 2017  According to the Centers for Disease Control and ... October . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the ... certain health insurance regulations. ... time to get a flu shot is by the end of October, ...
Breaking Medicine Technology: