Navigation Links
Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
Date:12/24/2007

COLLEGEVILLE, Pa., Dec. 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis.

In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by the Company's complete response to the first approvable letter. The FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events. The Agency also identified certain issues concerning data collection and reporting and requested additional source documents.

The FDA stated that the Wyeth Asian studies that were submitted on November 9 and December 14, 2007, were not reviewed for this action. Wyeth believes the data from these nearly 1,000 women provide additional support for a favorable benefit to risk ratio for bazedoxifene in the prevention of postmenopausal osteoporosis.

The Agency did not request the initiation of any new studies and has suggested an end-of-review conference between Wyeth and the FDA to address the remaining issues.

"We look forward to working with the FDA to resolve these issues. Wyeth is dedicated to identifying therapies for the millions of postmenopausal women who are at risk for increased bone loss," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals.

The Company received the first approvable letter on April 23, 2007, and submitted data requested in June 2007. In July 2007, Wyeth submitted a sep
'/>"/>

SOURCE Wyeth Pharmaceuticals
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Wyeth and Nycomed Announce Court Denial of Preliminary Injunction
2. Wyeths Pearl River, N.Y. Facility Celebrates 100 Years of Achievements in Health care
3. Wyeth Announces Election of Bernard Poussot as CEO of Company Effective January 1, 2008
4. Wyeth Announces the Election of Robert M. Amen to Its Board of Directors
5. Wyeth Comments on PREVNAR and Trends in Pneumococcal Disease
6. Wyeth to Appeal Nevada Hormone Therapy Trial Verdict
7. Wyeth Reports Earnings Results for the 2007 Third Quarter and First Nine Months
8. Wyeth Consumer Healthcare Initiates Voluntary Recall and Replacement Program for Several Robitussin Products and Childrens Dimetapp Cold & Chest Congestion
9. Wyeth Consumer Healthcare Announces the Availability of Centrum Cardio and New Formula Centrum Products
10. Wyeth to Present at the Credit Suisse First Boston Healthcare Conference
11. Wyeth Receives FDA Approval of Protonix for Delayed-Release Oral Suspension
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... July 23, 2014 The European Vitamins ... Europe with analysis and projection of revenue. The market ... million in 2012 to $1,202.08 million by 2018, at ... Browse through the TOC of the European Vitamins Market ... provided. This also provides a glimpse of the segmentation ...
(Date:7/23/2014)... European Bio fertilizers Market Report defines and segments the ... of revenue. The bio fertilizers market in Europe is ... 2012 to $4,582.2 million by 2017, at a CAGR ... the TOC of the European Bio fertilizers Market report, ... , http://www.micromarketmonitor.com/market/europe-bio-fertilizer-4637178345.html , The bio fertilizers ...
(Date:7/23/2014)... (July 23, 2014) Statins, a class of drugs ... patient,s risk of developing Barrett,s esophagus, according to a ... , the official journal of the American Gastroenterological Association. ... with statin use. , "Patients who received statins had ... Barrett,s esophagus compared to non-users," said study author Hashem ...
(Date:7/23/2014)... to a new market research report of "Semiconductor (Silicon) ... IP), Design Architecture (Hard IP, Soft IP), Processor Type ... & Analysis to 2013 - 2020", the semiconductor (silicon) ... of 12.6% from 2014 to 2020 and reach $5.63 ... data tables with 60 figures spread through 337 pages ...
(Date:7/23/2014)... identified three genetic changes linked to an increased risk ... investigators, was published online July 20 in Nature ... the most common malignancies among women worldwide, most studies ... focused on women of European ancestry. , Given the ... Asian women and those of European ancestry, the investigators ...
Breaking Medicine News(10 mins):Health News:Europe Vitamins (Nutraceuticals) Market is Expected to Reach $1,202.08 Million in 2018 - New Report by MicroMarket Monitor 2Health News:Europe Vitamins (Nutraceuticals) Market is Expected to Reach $1,202.08 Million in 2018 - New Report by MicroMarket Monitor 3Health News:Europe Vitamins (Nutraceuticals) Market is Expected to Reach $1,202.08 Million in 2018 - New Report by MicroMarket Monitor 4Health News:Europe Vitamins (Nutraceuticals) Market is Expected to Reach $1,202.08 Million in 2018 - New Report by MicroMarket Monitor 5Health News:Europe Bio Fertilizer Market is Expected to Reach $4,582.2 Million in 2017 - New Report by MicroMarket Monitor 2Health News:Europe Bio Fertilizer Market is Expected to Reach $4,582.2 Million in 2017 - New Report by MicroMarket Monitor 3Health News:Europe Bio Fertilizer Market is Expected to Reach $4,582.2 Million in 2017 - New Report by MicroMarket Monitor 4Health News:Statin use decreases the risk of Barrett's esophagus 2Health News:Semiconductor IP Market Estimated to Reach $5.63 Billion by 2020 – New Report by MarketsandMarkets 2Health News:Semiconductor IP Market Estimated to Reach $5.63 Billion by 2020 – New Report by MarketsandMarkets 3Health News:Semiconductor IP Market Estimated to Reach $5.63 Billion by 2020 – New Report by MarketsandMarkets 4Health News:Semiconductor IP Market Estimated to Reach $5.63 Billion by 2020 – New Report by MarketsandMarkets 5Health News:Semiconductor IP Market Estimated to Reach $5.63 Billion by 2020 – New Report by MarketsandMarkets 6Health News:Vanderbilt-led study identifies genes linked to breast cancer in East Asian women 2
... has found that alcohol does not kill off brain ... Queensland Brain Institute director Professor Perry Bartlett, the notion ... function similar to a napalm bomb strike, is erroneous. ... the world's top neuroscientists, claims that there is no ...
... Anderson Cancer Center have found in pre-clinical trials that ... in pancreatic cancer that shrinks or eradicates tumours, inhibits ... ,"This vehicle, or vector, is so targeted and ... used for therapy and perhaps for imaging," notes senior ...
... Residents in the United Kingdom would have to consider ... want to enjoy a pollution-free and greener future, a ... has said. ,According to the report, the ... operated cars and avoiding affordable flights. ...
... stroke patients practise daily tasks with impaired limbs, are ... Administration has approved a new robotic device called the Myomo ... arms. It is to hit the market shortly. ... weak electrical activity in patients arm muscles and providing just ...
... a new gene mutation that is associated with frontotemporal ... known as Prick's disease . ,Frontotemporal ... brain that control behaviour and language. Language problems, personality ... ,Unlike Alzheimer's disease, this Frontotemporal dementia does ...
... many of the genetic bits and pieces that drive ... disadvantages to humans or other animals. ,Nicholas ... Medicine said that the Hopkins experiments demonstrate that one ... DNA repeat elements that make up over 40 percent ...
Cached Medicine News:Health News:Gene Therapy Eradicates Pancreatic Cancer in Mice 2Health News:Brits Need to Change Lifestyle to Have a Greener Future: Report 2Health News:FDA Approve S Robotic Device to Help Stroke Patients 2Health News:FDA Approve S Robotic Device to Help Stroke Patients 3Health News:FDA Approve S Robotic Device to Help Stroke Patients 4Health News:Scientists Identify New Genetic Mutation Behind Common Dementia 2Health News:Completely Neutral Evolutionary Changes Helped Shape Our Genome 2
(Date:7/23/2014)... 23, 2014 On Tuesday, July 1, ... suit in the 116 th Judicial District ... against RegenLab USA, LLC ("Defendant") for ... Relationships through false and misleading actions, fraud, ... Disparagement through libel, disparagement, defamation, misrepresentation, and ...
(Date:7/23/2014)... July 23, 2014  RT Oncology Services Corporation today ... join its board of directors. Mr. Mundie is currently ... he works on strategic projects within the company and ... chief research and strategy officer. ... RainTree, said, "Craig is a visionary technology executive. His ...
(Date:7/23/2014)... /PRNewswire-iReach/ -- Use of Risk Evaluation and Mitigation Strategies ... market entry results in $5.4 billion in lost savings ... by economic consulting firm Matrix Global Advisors ... Required by the Food and Drug Administration ... are intended to improve drug safety by ensuring that ...
Breaking Medicine Technology:Craig Mundie Joins RainTree Oncology Board of Directors 2Craig Mundie Joins RainTree Oncology Board of Directors 3New Analysis Finds $5.4 Billion In Annual Lost Savings From Strategies Geared Toward Delaying Generic Drug Entry 2
... The SleepStyle 200 series offers a ... CPAP models. The design delivers therapy ... Performance features promote results in commercial ... The strongest differentiator in the SleepStyle ...
... The SleepStyle 200 series offers a ... CPAP models. The design delivers therapy ... Performance features promote results in commercial ... The strongest differentiator in the SleepStyle ...
The SleepStyle 600 series with ThermoSmart delivers humidification with anti-rainout benefits. ThermoSmart technology offers a heated breathing tube that allows the constant delivery of optimal level...
The S7 Lightweight offers the comfort and reliability of the award-winning S7 series in a convenient, affordable device....
Medicine Products: