FDA Re-Inspection Results in Positive Re-Classification of GuayamaFacility
MADISON, N.J., May 9 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE) today announced that the U.S. Food and Drug Administration's (FDA) San Juan District Office has informed the Company that the recent FDA re-inspection of its Guayama, Puerto Rico manufacturing facility has resulted in a positive re- classification of the site. The new classification means that any issues found by the FDA have either been corrected by the Company or do not merit any further regulatory action. Guayama will continue to serve as a strategic manufacturing site and a source for future Wyeth products.
"We are pleased that FDA has re-classified the Guayama facility and we were able to resolve its concerns in a satisfactory manner. The change in status allows for the timely approval of new products manufactured at the site," says Bernard Poussot, President, Chief Operating Officer and Vice Chairman, Wyeth. "We are committed to maintaining the highest standards of quality and compliance in our manufacturing operations around the world."
This re-inspection was related to the Warning Letter FDA sent to Wyeth in May 2006 regarding several specific concerns about manufacturing at Guayama.
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, including with respect to our 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: May 2007