MADISON, N.J., April 5 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that the U.S. Food and Drug Administration (FDA) has concluded its general re-inspection of the Company’s Guayama, Puerto Rico manufacturing facility. The re-inspection was related to an FDA Warning Letter received in May 2006 that raised several specific concerns about manufacturing at the facility.
Based on the nature of the inspection observations issued by the FDA, Wyeth is hopeful that it can respond to the remaining concerns and that the agency will be able to determine in the near future that the Warning Letter issues have been satisfactorily resolved.
Wyeth intends to respond in writing to the observations issued by the FDA inspector no later than mid-April and then will seek to continue its discussions with the agency regarding the overall compliance status of the facility.
“The conclusion of this inspection is an important step in advancing the resolution of the compliance issues raised,” says Bernard Poussot, President, Chief Operating Officer and Vice Chairman, Wyeth. “The Company believes we are in a position to submit adequate responses to the inspection observations.”
The Guayama facility also underwent a current Good Manufacturing Practices (cGMP) inspection by representatives of the European Medicines Agency (EMEA) during the week of March 26, 2007. That inspection was concluded successfully with no critical or major observations and Wyeth received a positive evaluation of the site’s compliance status.
The Company intends to provide an update on the status of its products under FDA review as part of its first quarter conference call scheduled for Thursday, April 19.
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. In particular, although it remains our goal to resolve the issues raised in the Warning Letter relating to our Guayama, Puerto Rico facility as quickly as possible, we cannot exclude the possibility that these issues will result in further regulatory action or delays in the approval of new products or release of approved products manufactured at the facility. Other 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.
Source: Wyeth
