Navigation Links
Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)
Date:12/14/2007

COLLEGEVILLE, Pa., Dec. 14 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced a regulatory update for Viviant.

Wyeth has submitted to the U.S. Food and Drug Administration (FDA) clinical study reports of two recently completed clinical studies of Viviant conducted in Asia. These data supplement Wyeth's pending New Drug Application (NDA) for Viviant for the prevention of postmenopausal osteoporosis and its "complete response" to the safety and efficacy issues raised in the FDA's April 23, 2007 approvable letter for this NDA.

Whether the complete response and this supplemental submission resolve to the FDA's satisfaction the issues raised in the approvable letter is not yet known. The current action date for the prevention NDA is at the end of December 2007, and no labeling discussions have occurred to date. FDA may issue an action letter by year-end or before, or may extend the review period by 90 days as a result of the recent submission.

The FDA action date for Wyeth's separate NDA for Viviant for the treatment of postmenopausal osteoporosis remains at the end of May 2008.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for peop
'/>"/>

SOURCE Wyeth
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Wyeth Sets Webcast and Conference Call for 2007 Third Quarter Earnings
2. Wyeth Announces $5 Billion Share Repurchase Program; Declares Increase in Common Stock Dividend
3. Wyeth Pharmaceuticals Acquires Haptogen Ltd. to Boost Biotechnology Drug Discovery
4. Wyeth Announces Election of New Principal Corporate Officer
5. Wyeth Declares Preferred Stock Dividend
6. Raven biotechnologies, inc. and Wyeth Pharmaceuticals Extend Evaluation Period of Selected Raven Antibodies
7. CardioDynamics Provides 2007 Shareholder Meeting Update
8. Pressure BioSciences, Inc. Reports Second Quarter 2007 Financial Results and Provides Business Update
9. NxStage Medical Provides Update on Medisystems Acquisition
10. VaxGen Files 2006 Financial Statements and Provides Cash Update
11. Signalife Provides Corporate Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... The Center for Professional Innovation ... training across the life sciences industry, has partnered with ... to provide the organization's members with discounted classroom courses, ... the more than 350 sessions across 80 course titles. ... when registering for a public course at ...
(Date:12/22/2014)... 2014 GenomeDx Biosciences today announced that a ... a genomic test for prostate cancer, was able to ... by radical prostatectomy without adjuvant therapy. Although rapid metastasis ... using tumor genomics to identify these men who have ... important advance. The study has been published online ...
(Date:12/22/2014)... (PRWEB) December 22, 2014 Fertility Associates ... Donor Egg Bank USA , a network of more ... Through this partnership, patients have fast access to a ... vitro fertilization, IVF . Fertility Associates of Memphis is ... this fertility treatment option. , Dr. William Kutteh ...
(Date:12/19/2014)... -- Naurex Inc., a biopharmaceutical company leveraging its unique ... central nervous system, today announced that Norbert Riedel ... at the 33 rd annual J.P. Morgan Healthcare ... p.m. PST on Tuesday, January 13, 2015, at the ... About Naurex Inc. ...
Breaking Biology Technology:CfPIE Announces Partnership with the Society for Clinical Data Management 2CfPIE Announces Partnership with the Society for Clinical Data Management 3Study Published in European Urology Shows that the Decipher Prostate Cancer Classifier is Predictive of Rapid Metastasis in High-Risk Men who have had Prostate Surgery 2Study Published in European Urology Shows that the Decipher Prostate Cancer Classifier is Predictive of Rapid Metastasis in High-Risk Men who have had Prostate Surgery 3Fertility Associates of Memphis Announces Partnership with Donor Egg Bank USA 2Fertility Associates of Memphis Announces Partnership with Donor Egg Bank USA 3Naurex to Present at 33rd Annual J.P. Morgan Healthcare Conference 2
... 2011  Hybrid Fuels, Inc., (Pink Sheets: HRID ... its new CEO and President.  Mr. Cadena was the ... EMG Marketing Solutions, and will be instrumental in implementing ...     Mr. Cadena has over 25 years ...
... Skills Related to Nutrition Care in ... Top-Tier Organization Elsevier/MC Strategies , a ... healthcare organizations announced today its collaboration with the ... to review and amend the nutrition-related skills in Mosby,s ...
... Energy, Inc., one of the world leaders in ... Acids Research Journal has published its white ... manipulation in algae."  As the site of photosynthesis in ... producing organic molecules from atmospheric carbon dioxide (CO2) ...
Cached Biology Technology:Hybrid Fuels, Inc. Appoints Industry Expert as New CEO 2Elsevier Collaborates with the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) 2Elsevier Collaborates with the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) 3Nucleic Acids Research Journal Publishes Sapphire Energy Peer-Reviewed Research Paper on a Chloroplast Genome From Green Algae 2
(Date:12/5/2014)... VIEW, Calif. , Dec. 4, 2014 /PRNewswire/ ... safety has boosted investments in new testing and ... has also given rise to a range of ... by the requirements of Generation Y, which is ... technologies. As a result, product development strategies of ...
(Date:12/3/2014)... As part of our commitment to offering ... to announce the release of a new reader that ... workforce data that they need. The Atlas ... existing readers. Many such devices have serious shortcomings when ... Older models force users to navigate numerous complicated steps ...
(Date:11/21/2014)... Wash. , Nov. 20, 2014 C-Labs ... for the Internet of Things (IoT), today announced the ... of chief operating officer. Previously a strategic advisor to ... finance, and operations. Mr. Traynor is based out of ... . He reports to Chris Muench , Chief ...
Breaking Biology News(10 mins):Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4Inception Technologies to Release New Biometric Reader 2C-Labs Names Former Microsoft and Bsquare Executive as Chief Operating Officer 2
... Scientists at IRB Barcelona have discovered that some brain ... use the genetic programme of germline cells to grow. ... brains. This finding demonstrates that these genes are crucial for ... is published today in the prestigious journal Science . ...
... study was carried out to examine the extent ... or insulin resistance in primary cultures of human ... cytokine elevated in the plasma and adipose tissue ... adipocytes were pretreated with quercetin and trans-RSV followed ...
... have succeeded in plugging a metal atom into a ... could be a key in opening up new production ... of organic compounds, which in turn might have implications ... is the first to determine the precise structure of ...
Cached Biology News:Some brain tumors mimic the genetic program of germline cells 2Study on effects of resveratrol and quercetin on inflammation and insulin resistance 2Milestone: A methane-metal marriage 2Milestone: A methane-metal marriage 3Milestone: A methane-metal marriage 4
... quadrupole 1200L sets the new standard ... - incorporating the latest technologies and ... chromatography analytical needs. The Atmospheric ... Transmission Quadrupole Analyzer provide superior selectivity ...
Human GFR alpha-4 Affinity Purified Polyclonal Ab...
Human Siglec-9 Biotinylated Affinity Purified Pab...
Human MFRP MAb (Clone 291218)...
Biology Products: