Navigation Links
FDA Re-Inspection Results in Positive Re-Classification of Guayama,Facility

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.

SOURCE Wyeth
-0- 05/09/2007
/CONTACT: Media, Douglas Petkus, +1-973-660-5218, or Wendy Kouba,
+1-484-865-5985; or Investors, Justin Victoria, +1-973-660 -5340, all of Wyeth/
/Web site: http://www.wyeth.com /
(WYE)


'"/>




Related medicine technology :

1. Point of Care Cardiac Analyzers Yield Rapid Cardiac Marker Results
2. Diagnosing Diabetes: Immediate HbA1c Results Improve Glycemic Control
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
5. Positive Aggrastat Results Featured in the Journal of the American College of Cardiology
6. Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy
7. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... ROCKVILLE, Md. , March 28, 2017 /PRNewswire/ ... dedicated to innovative therapeutics addressing cancer and other ... at the American Association for Cancer Research annual ... April 3 is entitled "Evaluation of ENMD-2076 ... and the second poster to be presented ...
(Date:3/28/2017)... Elysium Health joins major pharmaceutical ... Cambridge academic scientists through ... Milner Therapeutics Institute today announces Elysium Health as a partner ... investment for collaborative projects with academic researchers in ... the first major research investment outside the U.S. for the ...
(Date:3/27/2017)... WAUKESHA, Wis. , March 27, 2017  A ... one of only four freestanding hospitals in the country ... in plastic and reconstructive surgery, concluded that the Surfacide ... effective and integral component in reducing bacterial pathogens not ... The findings were published at the American Burn Association,s ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... Award-winning medical group Allied ... as new board chair for Orange County health care system CalOptima Friday. CalOptima ... soon-to-be former chair Mark Refowitz’s term, which runs through June 30 of this ...
(Date:3/28/2017)... MA (PRWEB) , ... March 28, 2017 , ... ... for direct measurement of corrosive ions found in power plant water and steam. ... components such as turbines and boilers, leading to extensive maintenance and unplanned shutdowns. ...
(Date:3/28/2017)... ... 2017 , ... A minimally invasive porcelain veneer is increasing ... Association of Dental Laboratories (NADL) is informing dentists about the benefits of minimally ... dental laboratories and technicians that create these veneers. , According to National ...
(Date:3/28/2017)... ... March 28, 2017 , ... The Lice Treatment Center® ... March 13-16, was a busy spot this year. Liz Solovay and Adrian Picheny, ... preventing outbreaks among camp communities during the upcoming 2017 camping season. “Lice infestations ...
(Date:3/28/2017)... ... , ... Thank you to all who attended Capio Partners Winter 2017 Healthcare ... exclusive to providers and offered an opportunity to collaborate and network with healthcare colleagues ... Hyatt where attendees gathered for a lively discussion on trends and issues that healthcare ...
Breaking Medicine News(10 mins):