Wyeth-Ayerst Pharmaceuticals

Anthony M. Cundell, Ph.D. Direetor, Microbiologieal Development, Wyeth-Ayerst Pharmaceuticals, Pearl River, New York Pharmaceutical Quality Assurance Microbiology Laboratories... 

Department of Pharmacology Physiology, New Jersey Medical School (UMDNJ), Newark, NJ 07101 VA Puget Sound Health Care System, Metabolism and Endocrinology Division, Seattle, Washington Wyeth Ayerst Pharmaceutical Company, Division of Neuroscience, Princeton, NJ, USA... 

Seattle, Washington Wyeth Ayerst Pharmaceutical Company, Division of Neuroscience,... 

Lo/Ovral (Wyeth-Ayerst) Modicon (Ortho-McNeil Pharmaceutical)... 

Norinyl (Searle) Ortho-Cept (Ortho-McNeil Pharmaceutical) Ortho-Cyclen (Ortho-McNeil Pharmaceutical) Ortho Novum (Ortho-McNeil Pharmaceutical) Ortho-Tri-Cyclen (Ortho-McNeil Pharmaceutical) Ovral (Wyeth-Ayerst) Tri-Levlen (Berlex) Tri-Norinyl (Searle) Triphasil (Wyeth-Ayerst)... 

On September 15,1997, FDA asked the manufacturers of dexfenfluramine (Redux manufactured for Intemeuron Pharmaceuticals by Wyeth-Ayerst) and fenfluramine (Pondimin Wyeth-Ayerst) to voluntarily withdraw both treatments from the market because of findings that indicate approximately 30% of patients taking the combined drugs had abnormal echocardiograms, even if they had no symptoms. Both companies agreed. FDA is not requesting the withdrawal of phentermine, the third widely used medication for obesity. 

Norplant is a registered trademark of the Population Council, It is manufactured and distributed by Leiras Pharmaceuticals in Finland, under license from the Population Council, It is marketed in the United States by Wyeth-Ayerst Laboratories, Inc, of Philadelphia. 

Manufacturers Monarch Pharmaceuticals, Bristol, TN (Pitocin) Wyeth-Ayerst, Philadelphia, PA (Oxytocin for Injection) Eon Labs, Laurelton, NY (Oxytocin Solution for Injection) Fujisawa, Deerfield, IL (Oxytocin Solution for Injection)... 

Second, the vaccine industry is small and unstable. It basically consists of four major pharmaceutical firms many smaller, older vaccine manufacturers and a number of biotech firms. In 2001, the dominant vaccine manufacturers in the U.S. market were Merck, Aventis Pasteur, Glaxo, and Wyeth-Ayerst (now Wyeth). Annual vaccine sales for these four firms are in the 1 billion range for each of the first three companies and around 500 million for Wyeth. Recent reports, such as those on the shortage of influenza vaccine, indicate that these firms confront a number of problems in vaccine production. A number of smaller firms hold FDA licenses for vaccines based on technology from earlier eras and face disincentives, including prohibitively high capital costs, to upgrade production capabilities to... 

Major pharmaceutical firms also devote substantial resources to train their professional workforce for dealing with FDA and complying with FDA regulations. We provide two examples Wyeth-Ayerst and Merck. Wyeth-Ayerst Global Pharmaceuticals, North America and Puerto Rico, requires that all personnel who participate in the... 

Altopiedi, Donna, Senior Director, Global Training and Continuous Improvement, Wyeth-Ayerst Global Pharmaceuticals, telephone interview, August 9, 2001. 

Fenfluramine (approved in 1973, withdrawn in 1997) and phentermine (appetite suppressant approved in 1959 and still available). Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, New Jersey, manufactured and marketed fenfluramine under the brand name Pondimin. Wyeth-Ayerst also marketed Redux (dexfenfluramine), which was manufactured for Interneuron Pharmaceuticals. See http //www.fda.gov/cder/news/phen/fenphenpr81597.htm... 

While the Abbott incident did not directly involve computer systems validation, persistent computer systems validation noncompliance should be regarded just as seriously. Other pharmaceutical manufacturing companies such as Wyeth-Ayerst, Johnson Johnson, and Schering-Plough have found to their detriment that persistent noncompliance can result in a most unpleasant outcome. Initial fines by the FDA on behalf of the U.S. Government have ranged from 30 to 575 million with ultimate costs as high as 1.5 billion (typically 16 to 24% of sales revenue). Senior executives have been identified as individual defendants in U.S. prosecutions. Beware that contempt of the law in the form of GxP practices does not threaten your business ... 

Pharmacia and Upjohn, Kalamazoo, MI) and Cri-none Gel (Wyeth-Ayerst). Mineral oil is frequently present in transdermal products such as Catapres-TTS (Boehringer Ingelheim) and Estraderm (Novartis Pharmaceuticals Corp). In addition, numerous ocular or topical ointments, such as TobraDex (Alcon Labs, Fort Worth, TX) and Nitro-Bid (Hoechst Marion Roussel, Kansas City, MO), use white petrolatum and mineral oil as a base. Short-chain triglycerides such as triacetin can be found in products such as Prepidil Gel (Pharmacia-Upjohn, Kalamazoo MI), a cervically administered prostaglandin. 

Dri-Pax [Wyeth-Ayerst]. TM for a group of silica-gel products used in packaging pharmaceuticals and similar products. Extends shelf life and deodorizes products having unpleasant odors. 

Ortho Pharmaceuticals, a subsidiary of Johnson Johnson, has had an ongoing contraceptive R D program. Eight companies that have discontinued Such R D are Syntex, Searle, Parke-Davis, Merck, Upjohn, Mead Johnson, Wyeth-Ayerst, and Eli Lilly (207). Wyeth-Ayerst, a subsidiary of American Home products, has renewed its contraceptive R D program in recent years, focusing on new forms of oral contraceptives (8,25 1). In addition, a relatively new, small firm, Gynco-Pharma, currently markets a copper IUD. Non-U.S. firms as well as universities and nonprofit foundations also carry on R D on new forms of birth control (207). 

Franco M. Pasutto, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta T6G 2N8, Canada Thomas W. Rosanske, Marion Merrell Dow, Inc., Kansas City, Kansas 64134 Charles M. Shearer, Wyeth-Ayerst Research, Rouses Point, New York 12979 Delores J. Sprankle, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285... 

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