SEARLE/PFIZER STATEMENT ON THE U.S. FDA ARTHRITIS ADVISORY COMMI
PR Wire December 1, 1998, 6:58 p.m. ET
Recommendation that Celebrex (Celecoxib) be Approved for Marketing
ST. LOUIS, Dec. 1 /PRNewswire/ -- Searle and Pfizer are pleased that the investigational compound Celebrex(TM) (celecoxib) received a recommendation for approval by the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA). Celebrex is currently under FDA review for acute or chronic use in the treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis and for the management of pain. The compound has been submitted as the first member of a new class of agents known as specific COX-2 inhibitors. The Committee unanimously recommended approval for the osteoarthritis and rheumatoid arthritis indications, and recommended that the indication for the management of pain continue to be discussed between the company and the FDA. The Committee's recommendation, however, is not binding on the FDA. The FDA will make the final decision on Celebrex's application.
Searle and Pfizer will continue to work closely with the FDA throughout the remainder of the review to help address outstanding issues.
Searle, a global leader in arthritis products and educational programs, is the pharmaceutical sector of Monsanto (NYSE: MTC) Company. Searle develops, produces and markets prescription pharmaceuticals, including major products to treat arthritis, cardiovascular disease, cancer and its complications, insomnia and women's health. For more information on Searle, access www.searlehealthnet.com. As a life sciences company, Monsanto is committed to finding solutions to the growing global needs for food and health by sharing common forms of science and technology among agriculture, nutrition and health. In 1997, Monsanto reported sales of $7.5 billion and invested nearly $1 billion in research and development.
Pfizer Inc. (NYSE: PFE) is a research-based healthcare company with global operations. In 1997, the company reported revenues of $12.5 billion and plans to invest approximately $2 billion in research and development in 1998.
SOURCE Monsanto Company
-0- 12/01/98
/CONTACT: Scarlett Lee Foster, pager, 800-557-2603, or Claudia Kovitz, 847-581-6786, both of Monsanto Company/
/Web site: monsanto.com
(MTC PFE)
CO: Monsanto Company ST: Missouri IN: MTC SU:
-0- Dec/01/1998 18:43 EOS (PRN) Dec/01/98 18:43 86 -0- (PRN) Dec/01/1998 18:58 |