Articles > Newspapers > International Newspapers, Major Markets > Biotech Week articles > September 2009

Article: Sanofi-Aventis Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri[R]) Submission.

Article from:
Biotech Week
Article date:
September 30, 2009
Copyright

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced 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 ). Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance (see also Regulatory Actions).

Sanofi-aventis is currently reviewing the content of the complete response letter, in which the FDA has requested ...

Read all of this article with a FREE trial

Related newspaper, magazine, and journal articles:

Article: FDA Issues Complete Response Letter to Ipsen for ...
Biotech Week;  January 14, 2009 ;     700+ words ... ... approval. The Complete Response Letter requests additional ... of review complete response letter, Ipsen expects to ... forth in the Complete Response Letter" said Stephane Thiroloix ... article was prepared by Biotech Week editors from staff ...

Article: Savient Pharmaceuticals Receives Complete Response ...
Biotech Week;  August 19, 2009 ;     700+ words ... ... The complete response letter from the FDA cites ... raised in the complete response letter. Under FDA regulations ... FDA in the complete response letter addresses a change ... article was prepared by Biotech Week editors from staff ...

Article: FDA Issues Complete Response Letter to Centocor for ...
Biotech Week;  December 31, 2008 ;     700+ words ... ... issued a Complete Response letter for its Biologics ... The Complete Response letter requests additional ... forth in the Complete Response letter," said Jerome A ... article was prepared by Biotech Week editors from staff ...

Article: Acura and King Receive FDA Complete Response Letter ...
Biotech Week;  July 15, 2009 ;     623 words ... ... issued a Complete Response Letter regarding the New ... The Complete Response Letter raises issues regarding ... FDA's Complete Response Letter, and at this stage ... article was prepared by Biotech Week editors from staff ...

Article: Labopharm receives complete response letter from ...
Biotech Week;  August 5, 2009 ;     684 words ... ... received a complete response letter from the U.S. Food ... the FDA's complete response letter to Labopharm, in ... article was prepared by Biotech Week editors from staff ... Copyright 2009, Biotech Week via NewsRx.com.

Article: FDA Issues Complete Response Letter to SCOLR ...
Biotech Week;  February 4, 2009 ;     664 words ... ... issued a Complete Response letter for its Abbreviated ... Development). The Complete Response letter requests additional ... article was prepared by Biotech Week editors from staff ... Copyright 2009, Biotech Week via NewsRx.com.

Article: FDA Issues Complete Response Letter for ...
Biotech Week;  August 12, 2009 ;     557 words ... ... received a Complete Response letter today for INTUNIV ... INTUNIV in the Complete Response letter or request new clinical ... article was prepared by Biotech Week editors from staff ... Copyright 2009, Biotech Week via NewsRx.com.

Article: ViroPharma Receives Complete Response Letter for ...
Biotech Week;  June 17, 2009 ;     700+ words ... ... received a Complete Response letter from the U.S. Food ... In the Complete Response letter, the FDA cited no ... article was prepared by Biotech Week editors from staff ... Copyright 2009, Biotech Week via NewsRx.com.

 
 
Newsweek Harper's Magazine The Washington Post Chicago Tribune Crain's Chicago Business PRNewswire Pediatric News The Nation Advertising Age The Economist (US) A FREE trial gives you access to over 80 million articles! Access over 6,500 publications with a FREE trial!

Find articles, research, and archives