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ADVISORY COMMITTEES TO FDA SPLIT VOTE ON NEW NONPRESCRIPTION PAIN RELIEVER; FDA CONTINUES REVIEW

 WASHINGTON, June 2, /PRNewswire/ -- Syntex Corp. (NYSE: SYN) and The Procter & Gamble Company (NYSE: PG) said today that the Arthritis and Over-The-Counter Drugs advisory committees to the United States Food and Drug Administration (FDA) voted 7-4 against recommending that FDA grant marketing approval for a new nonprescription pain reliever.
 Syntex and Procter & Gamble officials, FDA and its advisory committees are meeting later today to discuss confidential aspects of the submission, including proposed new product labeling.
 The proposed product would make available to consumers, for the first time, a nonprescription pain reliever containing the active ingredient in Naprosyn(R) (naproxen), the largest-selling prescription analgesic nonsteroidal anti-inflammatory drug (NSAID) in America. The proposed new analgesic contains 220 mg of naproxen sodium and is a faster-acting form of naproxen.
 "We are disappointed with the split vote, but will continue to work with the FDA on its evaluation of the New Drug Application," said Paul E. Freiman, Syntex chairman and chief executive officer.
 Syntex and P&G formed a joint venture in 1988 to develop and market certain nonprescription analgesic products. An NDA containing data on more than 7,000 patients, age 16 to 86, who participated in 33 clinical trials was submitted to the FDA in 1992. The NDA seeks permission to market the nonprescription pain reliever for the temporary relief, in adults and children age 12 and over, of headache, backache, muscular aches, toothache, minor aches and pains associated with common colds, minor pain of arthritis, pain of menstrual cramps and reduction of fever.
 Syntex Corp. is a multinational, research-based healthcare company dedicated to the discovery, development, manufacture and marketing of prescription medicines with approximately $2 billion in sales. OTC naproxen would be Syntex's first major non-prescription product.
 Procter & Gamble is the world's largest OTC company with nearly $3 billion in worldwide healthcare sales. P&G's healthcare business includes both prescription and nonprescription drugs which are available in 60 countries.
 -0- 6/2/93
 /CONTACT: Linda Thomas of Syntex, 301-230-6739, or, after June 2, 202-408-8440; or Kris Burbank of Procter & Gamble, 301-230-6739, or, after June 2, 513-945-8066/
 (PG SYN)


CO: Syntex Corp.; The Procter & Gamble Co. ST: California, District of Columbia, Ohio IN: MTC HEA SU:

TM -- SJ002 -- 4528 06/02/93 14:11 EDT
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Publication:PR Newswire
Date:Jun 2, 1993
Words:373
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