Navigation Links
VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
Date:12/14/2010

MOUNTAIN VIEW, Calif., Dec. 14, 2010 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010.  The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

VIVUS is pursuing regulatory approval to market QNEXA (phentermine/topiramate) Controlled Release Capsules in the U.S. for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

"Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress VIVUS is making in seeking U.S. approval of QNEXA® for the treatment of obesity," said Leland Wilson, chief executive officer of VIVUS. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA."

About QNEXA Controlled Release Capsules

QNEXA [kyoo-nek-suh] is an investigational drug 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 together decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss,
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. VIVUS to Present at Two Upcoming Investor Conferences
2. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
3. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
4. VIVUS Announces Sale of MUSE Assets to Meda
5. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
6. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results
7. VIVUS to Present at Lazard Capital Markets Healthcare Conference
8. VIVUS Announces Promotion of Peter Tam to President
9. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
10. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
11. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... , Oct. 21, 2014   BioNano ... the latest genomics research centers to purchase an ... Institute, the National Cancer Institute (NCI), NIH Intramural ... Center). Before Irys, obtaining a comprehensive view of ... generation sequencing (NGS) does not deliver the scalability ...
(Date:10/22/2014)... , Oct. 21, 2014 Influenza will affect ... deaths in the United States as ... are thought to spread is from person to person in ... has a serve way of death, but kills much fewer ... is also done by human fluids including sweat, saliva, blood ...
(Date:10/22/2014)... , Oct. 22, 2014 Sanomedics International ... 2014 report by Global Research & Data Services, demand ... year from 2014 through 2018, as demand for more ... is the world,s largest market for thermometers, ... advanced thermometers is Sanomedics International Holdings, Inc. ...
Breaking Medicine Technology:BioNano's Irys System Adopted by Leading Genomics Centers for Comprehensive Detection of Human Genome Structural Variation 2BioNano's Irys System Adopted by Leading Genomics Centers for Comprehensive Detection of Human Genome Structural Variation 3WholeHealth Products is proud to be releasing its Influenza A and B combo test, on the heels of the announcing of its phase 2 completion of the Rapid Ebola Test 2Sanomedics International Holdings Analyst Report: Taking Some Heat by BrokerBank Securities, Inc. 2
... Health System, recognized as one of the safest health ... HD by Talyst, a leader of pharmacy automation. The ... built-to-last 10 years guarantee. Berger Health System, ... implementing AutoPharm®, AutoPack™ and AutoLabel® to help reduce medication ...
... 2011 Clinicians at one of New Zealand,s leading hospitals ... newly-installed TrueBeam™ device in the first month of its ... VAR ) adds to Wellington Hospital,s radiotherapy ... The first patient in the country – ...
Cached Medicine Technology:Berger Health System Partners With Pharmacy Automation Leader to Improve Patient Safety 2Wellington Hospital, New Zealand Becomes First in Southern Hemisphere to Offer Patients Fast and Precise TrueBeam Treatments 2Wellington Hospital, New Zealand Becomes First in Southern Hemisphere to Offer Patients Fast and Precise TrueBeam Treatments 3
(Date:10/22/2014)... Angeles, California (PRWEB) October 22, 2014 Hay ... 2.0: Move Beyond Addiction and Upgrade Your Life (Paperback; $10.82) ... field of Yoga & Recovery. This book is meant ... thrive in a life of recovery. , Recovery 2.0 ... the 12 Steps; Recovery 2.0 is a guide for what ...
(Date:10/22/2014)... Losing Weight Your Body’s Way , In ... in the face, it certainly can be difficult to choose ... an extra favor by doing it the healthy way? Set ... listen to your body, exercise regularly, and choose foods with ... losing weight; you need to exercise more and eat less. ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. ... and length may be showing a genetic propensity for obesity ... genes have been linked to increased body fat, but the ... lean muscle, the researchers said. At 1 year, kids ... 2 and 3, however, these genes were linked to excessive ...
(Date:10/22/2014)... (HealthDay News) -- Measures taken by Firestone officials at ... may have limited the spread of the disease there ... Firestone Natural Rubber Co. provides health services to about ... densely populated communities. Between Aug. 1 and Sept. ... among those 80,000 people. That incidence rate of 0.09 ...
(Date:10/20/2014)... Allegheny General Hospital’s (AGH) Cardiovascular Institute is ... repair a damaged mitral valve as the heart continues ... by Abbott Vascular , is designed to treat ... in which the heart’s mitral valve leaflets fail to ... heart’s left ventricle into the left atrium. The heart ...
Breaking Medicine News(10 mins):Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 2Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 3Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 3
... the conscious businesses of the 21st century? Why not Bentley ... businesses that transform the world? Maybe that,s what your heart ... calling out to you to do." -- ... keynote address,to approximately 1,000 Bentley undergraduate students at the 89th,commencement ceremony ...
... ... display art and videos promoting seat belt use, CLEVELAND, May 17 , What: ... mobilization, When: Monday, May 19, 2008 ... The Cleveland House of Blues 308 Euclid Avenue ...
... Back; Merger Sets Up Healthy ... Retail Chain, LORTON, Va., May 16 Healthy ... workplace back wellness created an,ergonomic revolution, has acquired all ... Back,s 18 stores and ecommerce division,claimed 2007 revenues of ...
... report side effects, but critics want agency to act, ... -- Direct-to-consumer drug ads on television should include a ... adverse side effects, U.S. health experts suggested Friday. , ... U.S. Food and Drug Administration. Such phone numbers are ...
... the American Society of Clinical Oncology meeting in Chicago (Abstract ... patients with colon cancer and is the basis for proposed ... , This new study, using National Cancer Institute (NCI) ... III clinical trial data, shows that outcomes of patients with ...
... of the uterus (submucosal) are more likely to move to ... dont cause major complications, according to a new study. ... underwent an MRI examination before and after UAE. The study ... migrated to the endometrial cavity after UAE, said Sachit Verma, ...
Cached Medicine News:Health News:John Mackey, Chairman and CEO of Whole Foods Market(R), and Ellen M. Zane, President and CEO, Tufts Medical Center and the Floating Hospital for Children, Offer Advice to Bentley Students at May 17 Commencement 2Health News:John Mackey, Chairman and CEO of Whole Foods Market(R), and Ellen M. Zane, President and CEO, Tufts Medical Center and the Floating Hospital for Children, Offer Advice to Bentley Students at May 17 Commencement 3Health News:John Mackey, Chairman and CEO of Whole Foods Market(R), and Ellen M. Zane, President and CEO, Tufts Medical Center and the Floating Hospital for Children, Offer Advice to Bentley Students at May 17 Commencement 4Health News:John Mackey, Chairman and CEO of Whole Foods Market(R), and Ellen M. Zane, President and CEO, Tufts Medical Center and the Floating Hospital for Children, Offer Advice to Bentley Students at May 17 Commencement 5Health News:John Mackey, Chairman and CEO of Whole Foods Market(R), and Ellen M. Zane, President and CEO, Tufts Medical Center and the Floating Hospital for Children, Offer Advice to Bentley Students at May 17 Commencement 6Health News:Northeast Ohio Kicks Off the 2008 Click It or Ticket Campaign 2Health News:Northeast Ohio Kicks Off the 2008 Click It or Ticket Campaign 3Health News:The Back Wars Come to a Close 2Health News:FDA Panel Considers Toll-Free Number for TV Drug Ads 2Health News:FDA Panel Considers Toll-Free Number for TV Drug Ads 3
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
... offers a wide variety of financing options ... We are a direct lender to dentists ... finance has proven invaluable to our clients. ... and again for financial services because we ...
The Electri-Cool® II is the premier choice when it comes to localized cold therapy systems. system offers the widest variety of application-specific pads and wraps, for your convenience....
Medicine Products: