FDA stops short of approving Pristiq |
|
|
|
Published
:
Mon, 23 Jul 2007 23:50
|
WASHINGTON (AP) - Federal regulators on Monday stopped short of approving Wyeth's drug Pristiq to treat hot flashes and other symptoms of menopause.The Food and Drug Administration sent Wyeth a so-called approvable letter, according to agency spokeswoman Rita Chapelle, indicating the company's application is OK in many respects, but that staff scientists want more information about the treatment before approving it.Chappelle declined to provide additional information.The decision comes as a blow to Madison, N.J.-based Wyeth, which hopes to market the drug as the first non-hormonal treatment for menopausal symptoms.According to the analysts, Pristiq represents a major opportunity for the company because many U.S. women with menopause are not comfortable taking hormone products, which have been linked to increased risk of heart attacks breast cancer and stroke.Cowen and Co. analyst Steve Scala estimates the drug could post sales of analyst $300 million by 2012 if it is approved this year.A spokeswoman for Wyeth could not immediately comment on the news.Shares of Wyeth fell 52 cents to $55.48 in after-hours trading, after settling 40 cents higher on Monday to close at $56.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
|
|
|
|
Print this Story
Spain's CNE says Gas Natural can be party to Suez' 11.4 pct stake plans 