Navigation Links
VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction
Date:9/1/2011

MOUNTAIN VIEW, Calif., Sept. 1, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for its investigational drug candidate, avanafil, for the treatment of erectile dysfunction (ED). The target date for the FDA to complete its review of the avanafil NDA is April 29, 2012. In previously announced results from the pivotal phase 3 trials, patients treated with avanafil achieved significant improvement in erectile function compared to placebo. The avanafil development program included over 1,350 patients and avanafil was shown to be well tolerated and effective in treating patients with general ED and diabetics with ED. The long-term safety study also confirmed the results observed in the phase 3 studies.

"We are pleased with FDA's acceptance of our NDA. If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED," stated Peter Y. Tam, president of VIVUS.

About AvanafilAvanafil is an investigational oral medication being developed for the treatment of erectile dysfunction.  Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor licensed from Mitsubishi Tanabe Pharma Corporation. VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries.

About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL,
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. VIVUS Announces $45.8 Million Registered Direct Offering of Common Stock
2. VIVUS Reports Second Quarter and First Six Months 2011 Financial Results
3. VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
4. VIVUS to Present at Three Upcoming Investor Conferences in March
5. VIVUS Provides Regulatory Update on QNEXA NDA
6. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
7. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
8. VIVUS to Present at Two Upcoming Investor Conferences
9. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
10. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
11. VIVUS Announces Sale of MUSE Assets to Meda
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... Research and Markets ( ... the  "Global Operating Room Equipment Market 2014-2018" ... (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ,An operating room is ... a healthcare facility used to perform surgical ... equipment, which ensures patient care and enhanced ...
(Date:8/22/2014)... , Aug. 22, 2014 /CNW/ - On Aug. ... , the Canadian Medical Association (CMA) voted on ... any plant material, including medicinal cannabis. Bedrocan Cannabis Corp., ... supportive of the CMA motion. The CMA ... particular hazards associated with smoking any plant material, including ...
(Date:8/22/2014)... DUBLIN , Aug. 22, 2014 ... the "Global and Chinese Intravenous Catheter Industry Report ... The Global and Chinese Intravenous Catheter Industry Report 2014 ... state of the global intravenous catheter industry with a ... a basic overview of the industry including definitions, classifications, ...
Breaking Medicine Technology:Global Operating Room Equipment Market 2014-2018: Key Vendors are Getinge, STERIS, Stykron and TRUMPF Medical Systems 2Bedrocan Canada Statement Regarding Canadian Medical Association Motion on Smoking Marijuana 2Global and Chinese Intravenous Catheter Industry Report 2014 2
(Date:8/22/2014)... Japantown Dental is excited to announce that ... Air polishing is a technique used to remove external ... be caused by a number of factors, which are ... External stains include coffee, wine, tea, smoking and chewing ... such as tetracycline, and direct trauma to the tooth. ...
(Date:8/22/2014)... HealthDay Reporter FRIDAY, Aug. 22, ... on work disability chronically use powerful prescription painkillers, according ... 2007 and 2011, about 44 percent of people receiving ... each year. And the percentage using the drugs long-term ... in 2011. Experts said the trend is ...
(Date:8/22/2014)... 22, 2014 As the controversy ... ) in uterine surgeries continues to grow, Bernstein ... have decided to limit coverage of uterine morcellation. ... Blue Cross-Blue Shield of Massachusetts will no longer ... morcellation as of September 1, 2014. Other insurers ...
(Date:8/22/2014)... Mi40x , the latest guide from ... people how they can use a simple 4-minute trick to ... of weeks has caught the attention of Shane Michaels, prompting ... the most well-known bodybuilders in the industry, and if he ... that in itself is a testament to how effective this ...
(Date:8/22/2014)... (RA), a complex autoimmune disease that affects 1 ... not only cope with pain, disability and joint ... work, family life and marital functioning. While many ... and disability is common. In addition, some patients ... or side effects. Because of this, there is ...
Breaking Medicine News(10 mins):Health News:Japantown Dental Introduces Air Polishing 2Health News:Many U.S. Workers on Disability Use Narcotic Painkillers, Study Finds 2Health News:Many U.S. Workers on Disability Use Narcotic Painkillers, Study Finds 3Health News:Many U.S. Workers on Disability Use Narcotic Painkillers, Study Finds 4Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 2Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 3Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 4Health News:Mi40x: Review Exposes Ben Pakulski’s Guide to Packing on Lean Muscle Fast 2Health News:Study shows cognitive-behavioral coping skills training has positive effects on rheumatoid arthritis 2
... for prostate cancer may expect better results, on average, ... programs, and better still if the hospitals also have ... Ford Hospital. The study, which evaluated postoperative complications ... also found that those with fewer complications after the ...
... Black prostate cancer patients may not be getting ... to a first-of-its-kind study by researchers at Henry Ford ... surgery to remove diseased prostates. While it is ... why the results of radical prostatectomy are not as ...
... HealthDay Reporter , TUESDAY, May 15 (HealthDay News) ... arteries, it may not be useful to give them ... symptoms such as chest pain or shortness of breath, ... populations of post-angioplasty and post-bypass patients; screening asymptomatic patients ...
... the University of California, San Diego have peered inside a ... celebrated health benefits of omega-3 fatty acids. More profoundly, they ... these processes to short-circuit inflammation before it begins, or at ... The work is published in the May 14, 2012 online ...
... in combination with the drug letrozole, a standard hormonal therapy ... a team of UC Davis investigators has found. ... Clinical Cancer Research . "We found that the ... given together," said Michael DeGregorio, UC Davis professor of hematology ...
... 15, 2012 The U.S. Army Medical Department announced today ... the American College of Physicians (MACP). Only 43 medical leaders ... contributions to the field of internal medicine in at least ... awarded a Mastership in 2012. One of the Masters, Col. ...
Cached Medicine News:Health News:Fewer prostate cancer surgery complications found in teaching hospitals with fellowship programs 2Health News:Quality of care, other issues may cause worse results in black prostate cancer surgery patients 2Health News:Are Post-Angioplasty Stress Tests Unnecessary? 2Health News:Why omega-3 oils help at the cellular level 2Health News:Cancer vaccine combination therapy shows survival benefit in breast cancer 2Health News:US Army internal medicine Masters, Fellows honored by American College of Physicians 2Health News:US Army internal medicine Masters, Fellows honored by American College of Physicians 3Health News:US Army internal medicine Masters, Fellows honored by American College of Physicians 4
2.5V Incandescent source, 3X magnification, pocket-sized....
... via fiber optic for homogenous ... have bright halogen illumination for ... aural canal. Lithium-ion batteries ... Ring rheostat for fine control ...
All Keeler otoscopes have bright halogen illumination for clear and accurate visualization of aural canal. Lithium-ion batteries with quick recharge capability. Ring rheostat for fine control of il...
... Ri-scope® line offer patented Sensomatic® ... when picked up and switch ... Fiber-optic delivery of light from ... uniform illumination of examination area. ...
Medicine Products: