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:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical Services, ... solutions for injectable drug administration, today shared the results ... Adapter for improving the intradermal administration of polio vaccines. ... Vaccination Summit in May 2017 by Dr. Ondrej ... Department, World Health Organization (WHO), and recently published in ...
(Date:10/4/2017)... WESTWOOD, Mass. , Oct. 4, 2017  According to the Centers ... by the end of October . PhysicianOne Urgent Care is helping communities ... Westchester, NY , by offering no-cost* flu shots through ... , as mandated by certain health insurance regulations. ... The best time to get a flu shot is by ...
(Date:10/2/2017)...  AllianceRx Walgreens Prime, the combined central specialty pharmacy ... benefit manager Prime Therapeutics LLC (Prime), today officially began ... unveiling of new signage at its headquarters in ... a few other company-owned facilities across the country. This ... of whom will begin to see the AllianceRx Walgreens ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Global Healthcare ... scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare ... activity. The fun run is geared towards children of all ages; it is ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of ... Philippines. “The Journey: From the Mountains to the Mission Field” is the creation of ... taught all ages and currently teaches a class of ladies at her church, which ...
(Date:10/12/2017)... , ... October 12, 2017 , ... Planet Fitness, one ... U.S., announced today its plans to open a flagship location in Covington, LA at ... former Rooms To Go store next to Office Depot in the Holiday Square shopping ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized health ... expanded their existing home health joint venture through an agreement, effective October 1, ... joint venture home health company with Asante, delivering clinically integrated care, for the ...
(Date:10/12/2017)... ... , ... Leading pediatric oncology experts at Children’s National Health System ... of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by ... Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of the ...
Breaking Medicine News(10 mins):