Navigation Links
FDA Advisory Committee Recommends Approval of Qnexa®
Date:2/22/2012

MOUNTAIN VIEW, Calif., Feb. 22, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.

"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, President of VIVUS. "We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic."

The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application (NDA) that was submitted for Qnexa in October 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for Qnexa is April 17, 2012.Note to InvestorsVIVUS will hold a conference call to discuss this update today, February 22, 2012, beginning at 6:30 p.m. Eastern Time. You can listen to this call by dialing toll free 877-359-2916 or 224-357-2386. A 30-day archive of the call can be accessed at http://ir.vivus.com/.

About Qnexa Controlled Release CapsulesQnexa [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 Diabetes and obstructive sleep apnea. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impa
'/>"/>

SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin
2. Niiki Pharma Forms Scientific Advisory Board with Leading U.S. Oncologists
3. Aethlon Medical Establishes Sepsis & Inflammation Scientific Advisory Board
4. FDA to Review Potential New Use of XGEVA® (Denosumab) at Oncologic Drugs Advisory Committee Meeting
5. VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity
6. Delcath Appoints Gregory Gores, M.D. to Medical Advisory Board
7. FDA Psychopharmacologic Drugs Advisory Committee Recommends Approval of Alexzas ADASUVE™
8. FDA Advisory Panel Recommends Against Approval of Champion® Heart Failure Management System for Patients With Heart Failure
9. Bayers Drospirenone-containing Combination Oral Contraceptives: FDA Advisory Committees Affirm Positive Benefit-risk Profile and Recommend an Update of Labels to Reflect Information From Available Studies
10. PrimeraDx Appoints Leroy Hood to its Scientific Advisory Board
11. Digital ArtForms Debuts iMedic3D, a Radically Different Approach to Radiology, at RSNA ‘11, and Announces the Addition of Dr. Eliot Siegel and Dr. David Kim to Its Advisory Board Members
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... UPI ), a medical device company that develops, manufactures ... today reported financial results for the fiscal 2015 third ... the Company,s Urgent ®  PC Neuromodulation System grew 14.5% ... compared to $3.9 million in the third quarter of ...
(Date:1/22/2015)... 2015 /PRNewswire/ - Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the ... therapies for cardiovascular disease and overall health is pleased to ... 2014 and its outlook for 2015 from the CEO, Mr. ... We would like to take this opportunity to share ...
(Date:1/22/2015)... Jan. 22, 2015  Bio-Techne Corporation (NASDAQ: TECH ... first member of the new Simple Plex platform through ... launch represents the re-branding of the previously acquired CyPlex ... platform is a transformative immunoassay technology which integrates an ...
Breaking Medicine Technology:Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Bio-Techne Launches Simple Plex Platform 2Bio-Techne Launches Simple Plex Platform 3
... 15 Watermark Medical , Inc., a privately-held, ... market, has expanded the market reach of its Web-enabled ... three leading sleep solution providers in the U.S. and ... national provider of comprehensive sleep apnea services; Sleep ...
... Vista Partners announced today that it has updated ... Principal Analyst at Vista Partners stated, "Raptor is potentially ... a balanced pipeline of clinical and preclinical programs.  The ... programs and one Phase 3 trial with some indications ...
Cached Medicine Technology:Three Leading Sleep Solution Providers Choose Watermark Medical's Web-Enabled Home Sleep Testing Solutions 2Three Leading Sleep Solution Providers Choose Watermark Medical's Web-Enabled Home Sleep Testing Solutions 3Three Leading Sleep Solution Providers Choose Watermark Medical's Web-Enabled Home Sleep Testing Solutions 4
(Date:1/22/2015)... January 22, 2015 Padre Murphy's and Owner ... of Pro Player Health Alliance (PPHA). The PPHA's ... in getting everyone, including NFL greats, treated for obstructive sleep ... leading groups supporting the cause in the valley. The most ...
(Date:1/22/2015)... January 22, 2015 The Incredible Bulk is ... Pakulski to increase lean muscle by up to 30lbs in ... the attention of HealthyandFitZone.com’s Stan Stevenson, prompting an investigative review. ... is a step-by-step, scientific diet formula that allows the body ...
(Date:1/22/2015)... 2015 Blue Cross and Blue Shield of ... what it means to “Live Fearless.” , The ... share their stories about how they or someone they know ... by living in the moment. By telling these types of ...
(Date:1/22/2015)... The federal court overseeing thousands of vaginal mesh ... District of West Virginia has upheld a $2 million verdict ... trial. In an Order dated January 21st, the Court denied ... C.R. Bard had not proven a miscarriage of justice. (Cisson ...
(Date:1/22/2015)... Dallas, TX (PRWEB) January 22, 2015 ... the issue of experience and person-centeredness in the long-term ... moving towards action across the continuum. The paper, “The ... the Continuum,” engages perspectives and practices of the patient, ...
Breaking Medicine News(10 mins):Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 3Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3
... birth weight or were not breast-fed may be// at a ... the University at Buffalo who presented this finding at the ... is especially true for women in their pre-menopausal age. ... is the most important phase of life for the development ...
... omega-3 fatty acids in their diet during pregnancy and ... daughter’s risk of breast cancer., ,Scientists from Louisiana ... 96th Annual Meeting of the American Association for Cancer ... have diet rich in omega 3 fatty acids will ...
... study by the computational neuroscientist of Vanderbilt University have ... insight into neural circuits that play a role in ... make us apply previously learned rules on new situations ... that the new use of technology in understanding developmental ...
... that extracts of the grapefruit seeds contain antioxidants ... a fruit, grapefruit had been associated with acidity ... and helpful ingredients that have healing properties. Researchers ... and presented their study findings at the Digestive ...
... Regular use of aspirin among patients of colon cancer after ... or death. ,In a study which was presented at ... that the risk of recurrence reduces by about 50% for ... were diagnosed as suffering from colon cancer. ,Colon and ...
... that for people whose blood pressure do not lower //during ... ,In a healthy normal person blood pressure tends to lower ... sleep disturbances may elevate the nighttime blood pressures. ... levels of blood pressure at night may be the predictor ...
Cached Medicine News:
... High Speed Performance of Daily Routine ... Requirements and Information. VISUPAC has been ... Important for routine operation is the ... sequences. Extensive default settings reduce the ...
... Microscope with excellent maneuverability. Konan ... weight maintaining high quality. Easy ... by simply changing the adapter. ... has resulted in a sharp ...
... use with patients who have cataract and ... is a semicircular elastic PMMA ring for ... It is supplied in sterile packing for ... pupil during phacoemulsification for patients who have ...
To maintain the conjunctival cul-de-sacs after enucleation or evisceration without hindering lid closure....
Medicine Products: