Navigation Links
Topiramate Exposure and Birth Defect Data to be Presented at the 29th International Epilepsy Congress
Date:7/20/2011

f forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of our response to the FDA's requests from the End of Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy or FORTRESS; 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 in the development, the 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
'/>"/>
SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Spherics, Inc. Announces Reduced Cognitive Impairment of Novel Extended Release Topiramate (SRx-502) as Compared to Topamax(R)
2. Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
3. Upsher-Smith Laboratories Announces Initiation of Open-Label Extension Study of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
4. Data Suggests Positive Pharmacokinetic Results From Phase I Research of Extended-Release Topiramate
5. FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate
6. Phase I Research of Extended-Release Topiramate Shows Less Fluctuation in Plasma Levels
7. Vaccine Study in New England Journal of Medicine Wrong in Concluding Mercury Exposures are Harmless, States SafeMinds
8. Dynavax Begins TOLAMBA(TM) Environmental Exposure Chamber Study
9. HIV Prevention Expert Dr. Timothy Mastro Speaks on Future of Pre-Exposure Prophylaxis at International AIDS Conference
10. New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option
11. Two New Clinical Studies Show That Limited Exposure to Blood Transfusion Significantly Increases Morbidity and Mortality After Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... Dec. 17, 2014  Northstar Global Business Services, ... Company (DTC) has made their final decision and ... the Company,s stock effective December 15, 2014, and ... for depository and book entry transfer services. All deposit ... now once again fully "DTC Eligible", and has ...
(Date:12/17/2014)... BUENA, N.J. , Dec. 17, 2014  IGI ... announced today the closing of its offering of $125 ... due 2019 (the "Notes").  The Notes were offered and ... 144A under the Securities Act of 1933, as amended ... at a fixed rate of 3.75% per year, payable ...
(Date:12/15/2014)... 2014 Research and Markets ( ... "MEMS Gyroscopes Analog Devices ADIS16136 Precision Angular ... their offering. http://photos.prnewswire.com/prnh/20130307/600769 ... applications made a lot of progress in the ... are now accepted in high-reliability environments, and are ...
Breaking Medicine Technology:Northstar announces that the DTC chill on MDIN has been officially lifted 2Northstar announces that the DTC chill on MDIN has been officially lifted 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 2IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 4MEMS Gyroscopes Analog Devices ADIS16136 Precision Angular Rate Sensor Reverse Costing Analysis 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
... ... voice and visual mobile advertising network, today announced that it closed a $10 million ... ... visual mobile advertising network, today announced that it closed a $10 million Series B financing. ...
... common, but cases of eyelid cancer also up, study finds ... appendages, such as sweat glands, mammary glands, hair and nails, ... new study. , Because these cutaneous appendageal carcinomas are still ... new study, a team at the U.S. National Cancer Institute ...
... babies seem more likely to develop allergies, asthma, ... Babies who are born vaginally pick up different bacteria ... affecting how their immune systems develop, a new study ... into why babies born through cesarean sections appear to ...
... BPA, but study can,t confirm cause-and-effect, experts say , ... more troubling news about the ubiquitous plastics chemical bisphenol ... levels of the chemical in their bloodstream, a study ... syndrome (PCOS) develop multiple "cysts" -- immature follicles ...
... Jane Dyer, PhD, MS, CNM, FNP, MBA, associate professor ... Health Nurse Practitioner Program at the University of Utah ... American College of Nurse Midwives as one of the ... honor by three longtime colleagues and was selected by ...
... bisphenol A, or BPA, in the womb and early life ... new study conducted in animals. The results are being presented ... Diego. "We are seeing changes in the testis function ... than what the Food and Drug Administration and Environmental Protection ...
Cached Medicine News:Health News:Apptera Raises $10M to Grow Its Voice And Visual Mobile Ad Network 2Health News:Apptera Raises $10M to Grow Its Voice And Visual Mobile Ad Network 3Health News:Skin Appendage Tumors Seem on the Rise in U.S. 2Health News:Delivery Method May Determine the Bacteria Babies Acquire 2Health News:Delivery Method May Determine the Bacteria Babies Acquire 3Health News:Plastics Chemical BPA Tied to Ovarian Cysts 2Health News:Plastics Chemical BPA Tied to Ovarian Cysts 3Health News:Director of top 10 nurse midwifery program inducted into the American College of Nurse Midwives 2Health News:Early-life exposure to BPA may affect testis function in adulthood 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... 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 ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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 ...
Medicine Products: