Navigation Links
VIVUS Reports Topline Findings From FORTRESS
Date:12/21/2011

and Drug Administration, or FDA, to our resubmission of the New Drug Application, or NDA, for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, recommended for obese patients (BMI >/=30 kg/m2), or overweight patients (BMI >/=27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity), with a contraindication that excludes the use of Qnexa by women of child-bearing potential; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; the reliability of the electronic medical claims healthcare databases used in the FORTRESS study; the FDA's interpretation of and agreement with the information VIVUS submitted relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study (OB-305) and Sleep Apnea study (OB-204); that we may be required to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; our response to questions and requests for additional information including additional pre-clinical or clinical studies from the European Medicines Agency, or EMA, and the Committee for Medicinal Products for Human Use, or CHMP, of the Marketing Authorization Application, or MAA, for Qnexa; the results of external studies to assess the teratogenic risk of topiramate; results of the REMS or cardiovascular outcomes for obesity advisory meetings; the outcome of the second advisory committee meeting for Qnexa; the impact, if any, of the agreement by one of our competitors with an obesity compound to conduct or complete a cardiovascular outcomes study pre-approval; impact on future sales based on specific indication and contraindications contained in the label and extent of the REMS, distribution and patient access program; the FDA's response to the
'/>"/>
SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. VIVUS to Present at the Credit Suisse 2011 Healthcare Conference
2. VIVUS Resubmits Qnexa NDA to the FDA
3. VIVUS Provides Regulatory Update on QNEXA
4. VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction
5. VIVUS Announces $45.8 Million Registered Direct Offering of Common Stock
6. VIVUS Reports Second Quarter and First Six Months 2011 Financial Results
7. VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
8. VIVUS to Present at Three Upcoming Investor Conferences in March
9. VIVUS Provides Regulatory Update on QNEXA NDA
10. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
11. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... , Aug. 29, 2014 Research ... "Global Multiple Sclerosis Drugs Market 2014-2018" report ... a chronic, inflammatory medical condition that results in demyelination, ... because of an abnormal response by the immune system, ... It is a potentially debilitating disease in which the ...
(Date:8/29/2014)... -- Pixcelldata, the innovative Irish developer of ... major new deal with Dutch based eX-Path, global providers ... Marius Nap . The announcement was ... Pathology which is taking placing between August 30th and ... where Pixcelldata will demonstrate its innovative solution. ...
(Date:8/28/2014)...  Rigrodsky & Long, P.A.: , Do you, ... LCI )? , Did you purchase your shares before ... 2014, inclusive? , Did you lose money in your ... to discuss your rights? Rigrodsky & ... Timothy J. MacFall , announces that a complaint has been filed ...
Breaking Medicine Technology:Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 2Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 3Pixcelldata Announces New Deal with Dutch Tele-Pathology Specialists eX-Path Ahead of ECP 2014 2Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Lannett Company, Inc. 2Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Lannett Company, Inc. 3
(Date:8/30/2014)... As the economy continues to recover ... style bathrooms and in-home fitness centers, the North ... in interest not only in designing and installing saunas ... benefits of sauna. Through working with manufacturers across ... Sauna Society provides a strong knowledge base of Finnish ...
(Date:8/30/2014)... 2014 UWDress.com, a distinguished wedding dress supplier, ... first range of fashionable outfits. Recently, the company has unveiled ... As an autumn special offer, all these brand new products ... , “We are excited to unveil the new and ... high quality products are available at low prices now. The ...
(Date:8/30/2014)... 2014 Recently, Skmen.com, a well-known clothing ... casual dresses . Before the middle of September, all ... discounted price, from 15 to 30 percent off. ... long casual outfits are carefully made and come with ... for the wearers. Skmen.com is popular for its fashionable, ...
(Date:8/30/2014)... Patients suffering from vitiligo can now discover a ... published by Daily Gossip. , Vitiligo is a ... no wonder that numerous sufferers search for an alternative ... one of the most appreciated such methods at the ... the spread of this disorder immediately, while completely curing ...
(Date:8/30/2014)... 30, 2014 The term nutraceuticals ... Pharameuticals. Nutraceuticals is a source of healthy-dietary supplements ... natural food sources. Nutraceutical ingredients have certain curative ... human body. Nutraceutical health products include factors such ... and more. Although nature is the most bountiful ...
Breaking Medicine News(10 mins):Health News:As Interest in Saunas Increases, the North American Sauna Society Increases Outreach to Provide Education on History, Design, and Culture 2Health News:UWDress.com’s Beautiful Collection Of “Flowy Bridesmaid Dresses” Released 2Health News:Huge Deals On 2014 Long Casual Dresses Unveiled By Skmen.com 2Health News:Natural Vitiligo Treatment Review Exposes Fast Method for Skin Repigmentation 2Health News:A Granular Analysis of the Nutraceutical Ingredients Market by Transparency Market Research 2Health News:A Granular Analysis of the Nutraceutical Ingredients Market by Transparency Market Research 3Health News:A Granular Analysis of the Nutraceutical Ingredients Market by Transparency Market Research 4
... SHENZHEN, China, Feb. 13 /PRNewswire-Asia/ -- Winner Medical Group Inc.,(OTC ... financial results for the first quarter ended December 31,2008. The ... with,the United States Securities and Exchange Commission. , , ... Total net sales revenue increased by 33.14% over the first ...
... the University of Brighton Medical School has chosen a Mecmesin MultiTest ... orthopaedic prosthesis for shoulder reconstruction. , ... Slinfold, West ... orthopaedic surgeon at the University of Brighton Medical School has chosen ...
... share most of their genes, including 70 percent of ... remarkable evolutionary conservation, researchers at the Salk Institute for ... model for an innovative study of gliomas, the most ... disease but we still know very little about the ...
... 44%, researchers say , , THURSDAY, Feb. 12 (HealthDay News) ... much as a 44 percent increased risk of developing ... has established a connection between smoking and increased risk ... the largest review to date showing a link between ...
... Feb. 12 Biotel Inc.,(OTC Bulletin Board: BTEL) announced ... net earnings of $289,000, or $0.10 per diluted share,on ... $206,000, or $0.07,per diluted share, on revenues of $2,859,000 ... months ended December 31, 2008, Biotel had net earnings ...
... The Pennsylvania Department of Health has reviewed and ... Hospital in Brownsville, Fayette County, which ceased operations ... have been relocated to other facilities. All hospital ... work, assisted with the patient transfer.Local ambulances and ...
Cached Medicine News:Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 2Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 3Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 4Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 5Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 6Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 7Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 8Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 9Health News:Winner Medical Reports First Quarter Fiscal 2009 Results 10Health News:Force Tester Shoulders The Burden 2Health News:Fruit flies soar as lab model, drug screen for the deadliest of human brain cancers 2Health News:Fruit flies soar as lab model, drug screen for the deadliest of human brain cancers 3Health News:Secondhand Smoke Linked to Dementia 2Health News:Biotel Announces Profitable Second Quarter Ended December 31, 2008 2
... is based on SIREMOBIL Iso-C, the first ... the intra-operative 3D-Mode, the 3D-dataset is immediately ... orbital movement. This allows the surgeon to ... during the procedure. This 3D capability is ...
... Humphrey Field Analyzer II-i series is a ... the patient's visual field. ,By using SITA, ... is reduced by up to 70%. ,A ... ergonomic design to increase patient comfort while ...
... an innovative device designed to be a ... abdominal aortic aneurysms (AAA). It is constructed ... an outer self-expanding Nitinol support structure to ... The function of the endoprosthesis is to ...
... a cast from an arm or leg can ... cut or burned by the cast saw blade. ... remove any cast with confidence. This innovative, cut-resistant ... burns from the cast saw and can be ...
Medicine Products: