Navigation Links
Additional Analysis from Two-Year Sequel Study of QNEXA Featured at The 2011 Annual Scientific Meeting of The Obesity Society
Date:9/29/2011

retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners. As with any pharmaceutical in development, there are significant risks with development, regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA's CRL or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct any additional  prospective studies or retrospective observational studies, or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should r
'/>"/>
SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Unilife CEO to Purchase an Additional U.S. $500,000 in Company Shares by September 30, 2011
2. PLC Receives Two Additional U.S. Patents and First Japanese Patent For Its RenalGuard® Technology
3. Ingenuity Announces New Additional MicroRNA Content to Complement First-of-its-Kind MicroRNA Filtering Capability in IPA
4. Bionovo Announces an Additional 180 Day Period to Regain Compliance With Nasdaqs Bid Price Rule
5. ViroPharma Announces Additional Securities Repurchase Program
6. Omeros Unlocks Four Additional Orphan GPCRs
7. Auxilium Pharmaceuticals Announces Additional Data from Three-Year XIAFLEX® Recurrence Study in Dupuytrens Contracture in E-poster at ASSH Meeting
8. Auxilium Pharmaceuticals, Inc. and BioSpecifics Technologies Corp. Announce Plans to Develop Additional Indications using XIAFLEX®
9. Elsevier / MC Strategies Introduces Additional Resources to its ICD-10 Roadmap, Helping Healthcare Organizations Prepare for October 2013
10. HASCO Medical Chairman Provides $2 Million in Capital and a Personal Guarantee on Additional $2 Million Promissory Note
11. Nephros Receives 510k Approval to Market Additional Ultrafiltration Products
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2014)... Sept. 23, 2014 Research and ... "Physician Office Laboratory Markets, 3rd Edition" ... report, Physician Office Laboratory Markets is Kalorama,s complete ... industry. Physician office laboratories are diverse in their ... reimbursable, in-office pregnancy and glucose tests. Some specialty ...
(Date:9/23/2014)... , Sept. 23, 2014 This test can detect ... "risk event" is defined by activities that can transfer body ... or use of any shared needles. , An ... oral fluid. This HIV test works by looking for your ... results in 20 minutes, enabling patients to learn their status ...
(Date:9/23/2014)... 2014  Hill-Rom (NYSE: HRC ) today ... Renton, WA ), the nation,s third largest ... existing relationship as Hill-Rom now becomes Providence Health,s sole-source ... frame and surface products. Providence Health ... U.S.  It operates 34 hospitals, 475 physician clinics, 22 ...
Breaking Medicine Technology:Physician Office Laboratory Markets, 3rd Edition 2Physician Office Laboratory Markets, 3rd Edition 3WholeHealth Products announces the release of the FDA Cleared "HIV 1&2" Rapid Diagnostic Test for Professional and Retail 2Hill-Rom Announces Seven-Year, Sole-Source Contract with Providence Health 2
... (NASDAQ: SIAL ) today announced that its ... ), is introducing a novel CHOZN® GS-/- Zinc Finger ... for use in the production of biopharmaceuticals, the new ... glutamine synthetase (GS) knockout CHO cell line proven to ...
... LAS VEGAS, Oct. 26, 2011 Clinical Research Management, ... basic and applied research, clinical trials, and regulatory support, ... Boyer, Ph.D., will co-present a panel titled Battle ... the MAGI West Clinical Research Conference, October 23-26, 2011 ...
Cached Medicine Technology:SAFC Introduces the First Commercially Available Novel CHOZN® GS Knockout CHO Cell Line 2SAFC Introduces the First Commercially Available Novel CHOZN® GS Knockout CHO Cell Line 3SAFC Introduces the First Commercially Available Novel CHOZN® GS Knockout CHO Cell Line 4ClinicalRM to Co-Present Regulatory Compliance Panel at MAGI 2
(Date:9/23/2014)... As a consumer in today’s world, precautionary measures ... to trust testimonials that are supplied by the merchants ... customers into saying anything. , Consumer advocacy groups aim ... in depth coverage on a particular market i.e. nutrition. ... this issue and focus on exposing the thousands of ...
(Date:9/23/2014)... HealthDay Reporter TUESDAY, Sept. 23, 2014 (HealthDay ... breast milk is more likely than a blood transfusion to ... a new study finds. The researchers evaluated more than ... weighed 3.3 pounds or less and many who were born ... whether breast milk or transfusions carried the bigger risk. Infants ...
(Date:9/23/2014)... 23, 2014 (HealthDay News) -- A test used to diagnose ... where certain lung infections are more common, a new analysis ... is through the use of what,s known as functional imaging. ... FDG-PET is used, according to the study authors. Cancerous ... parts of the lungs that don,t have cancer, according ...
(Date:9/23/2014)... Genomic medicine is rapidly developing, bringing with its ... and optimize prevention and treatment interventions. Genetic ... immunodeficiency virus (HIV) and hepatitis c virus (HPC), ... be used to screen for an individual,s susceptibility ... treatments for addiction. , While there appear to ...
(Date:9/23/2014)... DC (PRWEB) September 23, 2014 ... care? The National Quality Forum (NQF) released ... ( http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77687 ), and an infographic ( http://bit.ly/1tX3lzA ... rising cost of healthcare, how patients define affordability, ... consumers to get the best possible healthcare at ...
Breaking Medicine News(10 mins):Health News:Consumer Health Reports Debuts Revolutionary Review Website 2Health News:Breast Milk a Risk for Spreading Common Virus to Preemies, Study Finds 2Health News:Breast Milk a Risk for Spreading Common Virus to Preemies, Study Finds 3Health News:Lung Infections May Hamper Ability to Detect Lung Cancer 2Health News:NYU-Mount Sinai Beth Israel study explores drug users' opinions on genetic testing 2Health News:Finding Affordable Care: Asking the Right Question is Key 2
... Enables PHNS and Healthcare Organizations to Audit, Enforce ... ... Regulations, BATON ROUGE, La., Nov. 16 TraceSecurity, a leading,provider ... its web-based Compliance Manager available to,hundreds of healthcare organizations across the ...
... to Improved HIV Management in Developing World, UPPSALA, ... has signed an agreement with a consortium of American ... of operational,funding, and has committed to raising additional funding ... Cavidi,s newly adopted three-year,business plan. Cavidi is the producer ...
... Agreement Ends Dispute Regarding Fee Disclosures for Separate ... ULLICO Inc. announced an,agreement resolving a Department of ... the Employee Retirement Income Security,Act of 1974 (ERISA). ... began as an inquiry,into ULLICO,s pension plan, ultimately ...
... Human Sexuality, Discussion on the Major Trends in Human Sexual Behavior, Sexual Desire, ... Sexual Dysfunction Issues, NEW YORK, Nov. 16 , WHAT: Are medicine and ... lead to better sex lives? What role does sex play in the ... and other compelling issues on human sexuality ...
... 16 HealthPartners,is the top-performing health plan in the ... newly released business report. The report, sponsored by the,National ... request for,information tool. The tool is used by purchasers ... Health Care Action Group, a coalition of,private and public ...
... November 15 - December 31, TULSA, Okla., Nov. ... today that it will offer three Medicare Part D,prescription ... eligible for Medicare. Medicare beneficiaries in Oklahoma can sign,up ... during the 2008,annual open enrollment period, which begins November ...
Cached Medicine News:Health News:TraceSecurity Announces Partnership with PHNS Expanding Compliance Services to Hundreds of Healthcare Systems 2Health News:TraceSecurity Announces Partnership with PHNS Expanding Compliance Services to Hundreds of Healthcare Systems 3Health News:New Investors Fund Expansion of Cavidi AB 2Health News:ULLICO Inc. and U.S. Department of Labor Agree to Resolve 5 Year Old ERISA Investigation 2Health News:ULLICO Inc. and U.S. Department of Labor Agree to Resolve 5 Year Old ERISA Investigation 3Health News:Charlie Rose Science Series 2Health News:HealthPartners is National Benchmark in Six Out of Seven Areas in National Business Coalition on Health Report 2Health News:Blue Cross and Blue Shield of Oklahoma Announces Flexible, Affordable Blue MedicareRx(SM) Medicare Prescription Drug Plans 2
Nucleus divider with 1.25 mm tip and blade offset at a 60 degree angle is ideal for performing the "Phaco Chop" technique to be used in left hand. Round knurled handle....
6 mm curved hook. Flat serrated handle with polished finish. Overall length: 4.7 inches. Most popular size or model....
Small bulbous tip with flat sides. Flat serrated handle with polished finish. Overall length: 5.1 inches....
7 mm flattened hook. Flat serrated handle with polished finish. Overall length: 4.9 inches....
Medicine Products: