Navigation Links
VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
Date:2/28/2011

A issued the CRL to communicate its decision that the NDA could not be approved in its present form.  The CRL included the following areas: clinical, labeling, REMS, safety update, and drug scheduling.  We held a meeting with the FDA on January 19, 2011, to discuss the items contained in the CRL.  At this meeting the FDA requested that we assess the feasibility of performing a retrospective observational study utilizing existing healthcare databases to review fetal outcomes in the offspring of women who received 100mg of topiramate for migraine prophylaxis during pregnancy. In the QNEXA studies, which included 15 births from women exposed to topiramate, there were no reports of any adverse fetal outcomes.

We expect to reach agreement with the FDA, and if deemed feasible, initiate the retrospective observational study on fetal outcomes within the next two months.  We will provide more details as soon as an agreement is reached.  It is our goal to resubmit the NDA for QNEXA by the end of 2011.

Although no other requests for additional information or studies were made by the FDA at the meeting, there can be no assurances that the FDA will not request or require us to provide additional information or undertake additional studies in connection with the QNEXA NDA.  

"In 2010, we also made significant progress with the development of QNEXA as a treatment for obesity by filing for approval in the European Union, and for avanafil we completed the pivotal phase 3 studies," stated Leland Wilson, chief executive officer of VIVUS. "We are working diligently on responding to the FDA's request to assess the feasibility of conducting a retrospective observational study. Our goals for 2011 include the continued advancement towards approval of QNEXA in the US and the EU and filing the NDA for avanafil."

Fourth Quarter ResultsIn November 2010, we sold MUSE and the related assets.  Accordingly, all historical financial
'/>"/>

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

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity
2. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
3. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
4. VIVUS Announces Promotion of Peter Tam to President
5. VIVUS to Present at Lazard Capital Markets Healthcare Conference
6. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
7. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results
8. VIVUS Announces Sale of MUSE Assets to Meda
9. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
10. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
11. VIVUS to Present at Two Upcoming Investor Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... -- NeuroCall, Inc., ("NeuroCall") announced today that it recently ... services. Dr. Ricardo Garcia-Rivera , Founder and Chief ... that our quality of service has been recognized by ... support and continuity of care to patients of our ... United States ." NeuroCall currently ...
(Date:10/1/2014)... ST. LOUIS , Oct. 1, 2014  Express ... its two nationally available 2015 Express Scripts Medicare ® ... retail pharmacy network featuring Walgreens (NYSE: WAG ... obtain more value, choice and clinical support  for their ... the Express Scripts Medicare Value or ...
(Date:10/1/2014)... , Oct. 1, 2014 ... a clinical-stage biopharmaceutical company focused on cardio-renal, ... results from its 371 patient Phase 2b ... constipation-predominant irritable bowel syndrome (IBS-C).  Results from ... meaningful improvement in IBS-C symptoms for tenapanor-treated ...
Breaking Medicine Technology:NeuroCall Awarded Joint Commission Accreditation 2Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network 2Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network 3Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network 4Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 2Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 3Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 4Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 5Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 6
... Dec. 4 The Michael J. Fox,Foundation for ... funding for five clinical research studies under its ... focus on,accelerating scientific solutions that can have a ... clinical research projects,with strong potential to yield new ...
... 3 CLL Survival Analysis Selected for ASH Press ... Genta,Incorporated (Nasdaq: GNTA ) announced that several ... featured at the annual meeting of the,American Society ... 7-11,2007. Programs involving Genasense(R) (oblimersen sodium) Injection,Genta,s lead ...
Cached Medicine Technology:Five Clinical Studies to Receive $2.5 Million Under Foundation's 2007 Clinical Discovery Program 2Five Clinical Studies to Receive $2.5 Million Under Foundation's 2007 Clinical Discovery Program 3Genta Clinical Programs Featured at American Society of Hematology Meeting 2Genta Clinical Programs Featured at American Society of Hematology Meeting 3Genta Clinical Programs Featured at American Society of Hematology Meeting 4
(Date:10/1/2014)... Engineering and Physical Sciences Research Council (EPSRC) will ... industrial control systems which run, for example, manufacturing ... rail network. , The research will help ... infiltrating the systems behind our critical national infrastructure. ... Control Systems (RITICS), based at Imperial College London, ...
(Date:10/1/2014)... Familylifeinsurancequotes.org has released a new blog ... citizens. , Senior citizens can qualify for affordable ... to seniors who are over 50 years old. Some ... a medical examination. , Term life insurance with a ... can qualify. Having life insurance during retirement is important ...
(Date:10/1/2014)... Lifeinsurance-policy.com has released a new blog ... prices for smokers. , Smoking will always have a ... is the best method to find affordable coverage. Insurance ... need coverage. , Whole life insurance premiums will ... Since the coverage is permanent, the initial rates ...
(Date:10/1/2014)... Farmington Company today announced it ... and visual identity helping brokers, consultants and companies ... to create greater benefit communication synergies. They unveiled ... empowering customers to better leverage Farmington Company’s industry-tested ... of the rebrand is the refreshed tagline: For ...
(Date:10/1/2014)... Maine (PRWEB) October 01, 2014 Between ... disorders in the U.S., according to figures from the ... Related Diseases Association (AARDA), and many of them have ... chance of having undiagnosed celiac disease. Gluten Free ... raise awareness of undiagnosed celiac disease by publishing a ...
Breaking Medicine News(10 mins):Health News:£2.5 million to recognize and reduce cyber-attack threats to critical infrastructure 2Health News:Affordable Term Life Insurance - Senior Citizens Can Qualify for Coverage! 2Health News:Affordable Whole Life Insurance Premiums for Smokers! 2Health News:Farmington Company Launches Rebrand and New Positioning 2Health News:Informative New Blog Series Underscores Link Between Celiac Disease and Other Autoimmune Disorders 2Health News:Informative New Blog Series Underscores Link Between Celiac Disease and Other Autoimmune Disorders 3
... The U.S. Food and Drug Administration (FDA) has decided ... (R) (infliximab) to be used in the treatment of ... today. Crohn's disease affects the gastrointestinal tract and causes ... now there is no drug to treat children who ...
... Illinois at Chicago in collaboration with their colleagues from ... enzyme in the virus that causes SARS//, severe acute ... in the March 27 issue of the Proceedings of ... form a new drug target for drug makers. ...
... the cause of four men whose lives took a turn ... German company// TeGenero and medical research company Parexel, has received ... handling the case, has felt ignored after receiving no response ... conducted at Northwick Park Hospital in Harrow, north-west London, last ...
... It is already known to us that some popular spices ... Liu, an assistant professor of obstetrics// and gynecology at the ... powder dissolved in solution by putting it on ovarian cancer ... that ginger can kill ovarian cancer cells. But the study ...
... Harris Interactive? for the Vagisil Women's Health CenterSM conducted a ... of today's American women are taking active roles in their ... thirds of women aged 18 and older (63 percent) report ... go to a gynecologist, 61 percent say they "always" go ...
... the risk of coronary heart attack and could in general be ... study of 4,400 men and women aged 65 and over by ... a link between the amount of alcohol drunk and the likelihood ... ,People who drink 14 or more glasses of wine or ...
Cached Medicine News:Health News:FDA Accords Priority Review For Pediatric Crohn's Disease Drug 2Health News:Spices Could Be Employed To Treat Certain Cancers 2Health News:Women aware of “feminine health” : their attitud 2
Multi piece lens, AC depth: 4.2....
Liberty Three Piece PMMA Lens with UV Absorber....
... Lenses: The Bausch & Lomb PMMA Posterior Chamber ... primary implantation for the visual correction of aphakia ... where a cataractous lens has been removed by ... be placed in the ciliary sulcus or capsular ...
... patients to focus seamlessly near, ... way the eyes natural lens ... to a remarkable new level. ... patients vision to the way ...
Medicine Products: