ViviantTreatment for Prevention of Osteoporosis
Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)
COLLEGEVILLE, Pa., December 14, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , 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 people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward- looking statements, whether as a result of new information, future developments or otherwise.
Posted: December 2007
- Wyeth Receives Approvable Letter From FDA for Bazedoxifene for the Treatment of Postmenopausal Osteoporosis - May 27, 2008
- Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis - Dec 26, 2007 - December 26, 2007
- Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis - May 1, 2007 - April 24, 2007
- Wyeth Submits Two NDAs for Women’s Health Therapies - June 26, 2006