Navigation Links
VIVUS Provides Regulatory Update on QNEXA
Date:9/15/2011

estimated to have a BMI >30 (obese) or BMI >27 (overweight) with at least one weight-related health risk, such as diabetes, hypertension or dyslipidemia. Of these, over three-quarters, or an estimated 80 million adults, are men and women of non-childbearing potential who are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.

"Topiramate teratogencity data published and presented since our last meeting with the FDA in April 2011 includes two case-control studies utilizing the CDC's National Birth Defects Prevention Study and the Slone Epidemiology Birth Defect Study presented at the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Chicago; and the Wolters Kluwer Study presented at International Epilepsy Congress in Rome. In addition, a birth defect study from Denmark on Newer Generation Antiepileptic Drugs including topiramate was published in JAMA.  In all of these studies, the authors concluded that topiramate was not a major teratogen," commented Wesley Day, vice-president clinical development.  "The conclusions reached in all of these studies were instrumental in the development of the QNEXA NDA resubmission plan."

About FORTRESSFORTRESS, for Fetal Outcome Retrospective TopiRamate ExpoSure Study, is a retrospective observational study utilizing existing electronic healthcare databases to assess fetal outcomes, in the offspring of women who were exposed to topiramate during the first trimester of pregnancy.  FORTRESS is expected to include approximately 2,500 topiramate exposed mother-infant pairs or dyads and is believed to be the largest retrospective topiramate medical claims study ever completed.  The co-primary endpoints will be the relative risk of major congenital malformations and oral cleft in the offspring of women exposed to topiramate during pregnancy as compared to a control group that was not exposed to topiramate. FORTRESS is ex
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction
2. VIVUS Announces $45.8 Million Registered Direct Offering of Common Stock
3. VIVUS Reports Second Quarter and First Six Months 2011 Financial Results
4. VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
5. VIVUS to Present at Three Upcoming Investor Conferences in March
6. VIVUS Provides Regulatory Update on QNEXA NDA
7. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
8. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
9. VIVUS to Present at Two Upcoming Investor Conferences
10. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
11. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... , December 15, 2014 Heptares ... company, is pleased to announce the grant of multiple ... relating to its GPCR-focused drug discovery platform. The ... the global patent estate covering Heptares, technologies and products ... of patents recently granted by the US Patent Office ...
(Date:12/13/2014)... 2014  Radiologists can transmit their reports, which ... referring physicians, electronic health records (EHR) systems securely, ... That was the message behind ... at the recent Radiology Society of North America ... reports in this manner also helps referring physicians ...
(Date:12/13/2014)... PLAINSBORO, N.J. and INDIANAPOLIS , ... diabetes care, and Chip Ganassi Racing Teams (CGRT), today announced ... Nordisk as the primary sponsor of the No. 83 Novo ... in the Verizon IndyCar Series. Kimball, ... first and only licensed driver with diabetes in the history ...
Breaking Medicine Technology:Heptares Extends Global Patent Protection for GPCR-Focused Drug Discovery Platform With Grant of Core Patents in the United States 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 3Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 2Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 3Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 4Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 5Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 6Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 7
... (Nasdaq: ELGX ), developer of minimally ... publication of results from its pivotal, multicenter, prospective ... endovascular repair of abdominal aortic aneurysm (AAA) using ... extension. The trial demonstrated 100% ...
... A class action lawsuit alleging deceptive business practices has ... giant sold millions of tubs of infant powder formula that ... lawsuit, which was brought in federal court in Chicago, was ... a newborn baby boy.  The suit alleges that Abbott knew ...
Cached Medicine Technology:Endologix Announces Publication of Clinical Trial Results Supporting Anatomical Fixation with a Suprarenal Aortic Extension 2Endologix Announces Publication of Clinical Trial Results Supporting Anatomical Fixation with a Suprarenal Aortic Extension 3Parents Bring Federal Lawsuit After Tainted Baby Formula Injures Newborn 2
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... according to McMaster University’s researchers. Neuroscientist Sandra Witelson led ... between women and men. // The study which was ... in women, verbal intelligence was clearly co-related with brain ... ,However, in men, this was true ...
... psoriasis condition are more likely to smoke, and smoking contributes ... scaling of the skin, and affect places like legs, scalp, ... of the feet. The chances of people with psoriasis suffering ... published in the Archives of Dermatology. ,Data ...
... from autopsy studies that women with Alzheimer’s disease have low ... than women with a sound mental health. // The research ... the University of Chicago. ,Previous studies conducted on ... the brain tissue can speed up the build up of ...
... is an outbreak of flu and it is presumed that this ... , In Texas and Colorado the flu case increased greatly ... , In Georgia the State Health Department reports to the press ... ,The Centers for Disease Control and Prevention in Atlanta cautions ...
... The New York City Department of Health and Mental Hygiene ... in India, for containing "dangerous levels" of lead and mercury. ... the Food and Nutrition Board of the Institute of Medicine ... no more than 2 ppm (parts per million) of lead ...
... The drinking behavior of tobacco users is related to ... to alcohol, according to a study. The connection which ... be because of the genetic risk factors which overlap. ... often go together. Dr. Kirk C. Wilhelmsen is the ...
Cached Medicine News:Health News:Lack Of Estrogen In Brain Tissue Of Women Can Lead To Alzheimer's 2Health News:NY Health Dept Bans 3 Ayurveda Drugs 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: