Navigation Links
Boehringer Ingelheim Comments on June 18th FDA Advisory Committee Meeting
Date:6/18/2010

RIDGEFIELD, Conn., June 18 /PRNewswire/ -- The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women.  The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA).  The FDA will consider the committee's advice as part of its final assessment of the NDA.  

The committee recognized the significant unmet medical need for women with HSDD and the lack of approved treatments for this condition.  Members of the committee advised that additional data are necessary to further support the efficacy and safety profile of flibanserin and recommended that clinical development of the drug continue.

"We are disappointed with the advisory committee's recommendations and will work with the FDA to address questions raised by the advisory committee," said Christopher Corsico, M.D., M.P.H., U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc.  "Our ongoing flibanserin clinical trial program demonstrates our continued commitment to women with HSDD."


'/>"/>
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1

Related biology technology :

1. Boehringer Ingelheim Receives Top Honor as Worlds Most Respected Biopharmaceutical Employer in Science 2007 Top Employers Survey
2. Dalton Medicinal Chemistry Partners Achieves Milestone in Collaboration with Boehringer Ingelheim (Canada) Ltd.
3. Astellas and Boehringer Ingelheim Reach Settlement Agreement with Ranbaxy on Flomax Patent Case
4. Dalton Medicinal Chemistry Partners Achieves Another Milestone in Collaboration with Boehringer Ingelheim (Canada) Ltd.
5. Boehringer Ingelheim Pharmaceuticals, Inc. Receives the NCQA Seal Of Approval
6. More Than Half of Patients Treated for Benign Prostatic Hyperplasia Receive Boehringer Ingelheims Flomax as First-Line Therapy
7. Boehringer Ingelheim and BioSpace Search for Scientists at Career Fair in Boston, Massachusetts
8. Rentschler Biotechnologie Announces Cooperation with Boehringer Ingelheim
9. Ingenuity Systems Announces Multi-Year Agreement With Boehringer Ingelheim
10. Boehringer Ingelheim and Micromet Announce Global Collaboration for Multiple Myeloma BiTE Antibody
11. Former Banc of America Securities Analyst David Maris Comments on Decision by Biovail to Drop Its Claims Against Him; Denies That He is Cooperating With Biovail
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... ... May 05, 2016 , ... American ... two additional patents, U.S. Patent Nos. 9,322,133 and 9,322,134, to API and its ... nanocellulose as well as hydrophobic nanocellulose compositions. In addition to these patents ...
(Date:5/5/2016)... BELL, Pa. , May 5, 2016  Why ... Powers and Lorna Weir launching a ... un-agency way? Because they believe that truly helping clients ... world of healthcare now demands a different type of ... strategy lab serving the pharmaceutical, biotechnology and medical device ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... previously announced identification of its first three targets, it has identified a fourth ... beta (Aß), implicated in the development and progression of Alzheimer’s disease (AD). ...
(Date:5/4/2016)... ... 2016 , ... CereScan, the nation’s leader in providing statistically ... Stroke Awareness Month in May. An infographic created by CereScan will be ... will donate $1 up to a maximum of $3,000 through users who share ...
Breaking Biology Technology:
(Date:5/3/2016)... 2016  Neurotechnology, a provider of high-precision biometric ... Biometric Identification System (ABIS) , a complete system ... ABIS can process multiple complex biometric transactions with ... fingerprint, face or iris biometrics. It leverages the ... MegaMatcher Accelerator , which have been used ...
(Date:4/28/2016)... and BANGALORE, India , April 28, ... Systems, a product subsidiary of Infosys (NYSE: INFY ... announced a global partnership that will provide end ... use mobile banking and payment services.      (Logo: ... key innovation area for financial services, but it also plays ...
(Date:4/28/2016)... , April 28, 2016 First quarter ... (139.9), up 966% compared with the first quarter of 2015 ... totaled SEK 589.1 M (loss: 18.8) and the operating margin was ... (loss: 0.32) Cash flow from operations was SEK 249.9 ... 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. The ...
Breaking Biology News(10 mins):