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:4/19/2017)... MA (PRWEB) , ... April 19, 2017 , ... ... a $1.5M Series A-1 financing round. This event adds to several other early ... of its’ Executive and Scientific Teams. , ThermaGenix will use proceeds ...
(Date:4/19/2017)... Linda, Ca (PRWEB) , ... April 19, 2017 ... ... University Virtual Event, which makes educational webinars accessible to novices as well ... impact of preanalytical variables of commonly performed coagulation screening tests. , Hemostasis ...
(Date:4/19/2017)... , April 19, 2017  As a ... Abuse and Heroin Summit ,  Proove® Biosciences, Inc. ... analyzing genetics, environmental, and lifestyle factors to accurately ... the University of Southern California (USC), the Interventional ... and Proove publish results showing that Proove Opioid ...
(Date:4/19/2017)... , April 19, 2017 ... today announced that it will report its first ... on Wednesday, May 3, 2017. Following the announcement, Veracyte,s management will ... p.m. Eastern Time to discuss the company,s financial results ... and subsequent replay may be accessed by visiting Veracyte,s website ...
Breaking Biology Technology:
(Date:3/27/2017)... 27, 2017  Catholic Health Services (CHS) has ... Society (HIMSS) Analytics for achieving Stage 6 on ... . In addition, CHS previously earned a place ... an electronic medical record (EMR). "HIMSS ... of EMR usage in an outpatient setting.  This ...
(Date:3/23/2017)... DUBLIN , Mar. 23, 2017 Research ... Anti-Theft System Market Analysis & Trends - Industry Forecast to 2025" ... ... to grow at a CAGR of around 8.8% over the next ... This industry report analyzes the market estimates and forecasts for all ...
(Date:3/20/2017)... HANOVER, Germany , March 20, 2017 At ... Hamburg -based biometrics manufacturer DERMALOG. The Chancellor came to the ... Japan is this year,s CeBIT partner country. At the largest ... important biometrics in use: fingerprint, face and iris recognition as well as ... ...
Breaking Biology News(10 mins):