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:2/9/2016)... ... 09, 2016 , ... The publishing industry has been witnessing ... one of the popular publication models that has received wider acknowledgement from the ... International Conferences across the globe, OMICS International is all set to ...
(Date:2/9/2016)... HOUSTON , Feb. 9, 2016 /PRNewswire/ ... virus-driven immunotherapies for cancer, announced that its ... the European Commission as an orphan medicinal ... the deadliest form of glioma, strikes approximately ... and EU. http://photos.prnewswire.com/prnh/20160208/330986LOGO ...
(Date:2/9/2016)... and LONDON , February 9, 2016 ... bio tech replace paper and protect IP ... electronic laboratory notebook (ELN) will be rolled out in ... research and development (R&D) and protect valuable IP. Users will ... follow a specific researcher or experiment as part of the ...
(Date:2/9/2016)... 9, 2016 BERG, a biopharmaceutical company ... approach, has announced the appointment of Jason ... Operating Officer. Haddock brings to BERG over 20 ... years in senior financial functions at pharmaceutical companies, ... organizational management. Niven R. Narain ...
Breaking Biology Technology:
(Date:1/22/2016)... , January 22, 2016 /PRNewswire/ ... announced the addition of the  "Global ... their offering. --> http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ... the  "Global Behavioral Biometric Market 2016-2020" ... Research and Markets ( http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ) ...
(Date:1/20/2016)... 2016  Synaptics Incorporated (NASDAQ: SYNA ), ... announced sampling of S1423, its newest ClearPad ® ... screen applications including smartwatches, fitness trackers, and touch ... rectangular shapes, as well as thick and curved ... on screen, while wearing gloves, and supports swipes ...
(Date:1/11/2016)... 2016 Synaptics Incorporated (NASDAQ: SYNA ), ... that its ClearPad ® TouchView ™ 4300 ... separate categories in the 8 th Annual Mobile ... Breakthrough. The Synaptics ® TDDI solution enables faster ... thinner devices, brighter displays and borderless designs. ...
Breaking Biology News(10 mins):