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FDA UPDATES ADVISORY COMMITTEES ON OTC NAPROXEN; LABELING DISCUSSIONS WITH FDA CONTINUE

 WASHINGTON, D.C., Sept. 8 /PRNewswire/ -- Syntex Corp. (NYSE: SYN) and The Procter & Gamble Co. (NYSE: PG) said today that the U.S. Food and Drug Administration (FDA) updated its advisory committees on the New Drug Application (NDA) for OTC naproxen, and that the companies will continue their discussions on labeling for the product with the FDA.
 At a meeting of the Arthritis and Nonprescription Drugs Advisory Committees today, the FDA described the steps Syntex and P&G have taken to address issues voiced by committee members when they considered the OTC naproxen NDA in June. The companies are recommending a maximum daily dose of 600 mg (3 tablets), with an 8-12 hour interval between doses, for people between ages 12 and 65; a maximum daily dose of 400 mg (2 tablets), with a 12-hour interval between doses, for people over 65 years of age; and use by children under 12 only upon the advice, and under the supervision of, a physician. In addition, a toll-free telephone number for consumer information and feedback will be included on the product label.
 Syntex and P&G declined to speculate when approval of the application may be granted or to provide further details on labeling and promotional materials.
 OTC naproxen would make available to consumers, for the first time, a nonprescription pain reliever containing the active ingredient in Naprosyn(R) (naproxen), the largest-selling brand in its class in America. OTC naproxen (naproxen sodium) contains 200 mg of naproxen in a fast-acting, nonprescription formulation that optimizes absorption into the body.
 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 who participated in 34 clinical trials was submitted to the FDA in 1992. The NDA seeks permission to market OTC naproxen 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.
 OTC naproxen would compete in the $2.3 billion U.S. OTC analgesic market, with acetaminophen, aspirin and ibuprofen. The new product would introduce for the first time in nearly a decade a nonprescription pain reliever containing a new analgesic ingredient.
 Syntex Corp. is a multinational, research-based health care company dedicated to the discovery, development, manufacture and marketing of prescription medicines, with more than $2 billion in annual sales. OTC naproxen would be Syntex's first major nonprescription product in the United States.
 Procter & Gamble is the world's largest OTC company with nearly $3 billion in worldwide health care sales. Procter & Gamble's health care business includes both prescription and nonprescription drugs, which are available in 60 countries.
 -0- 9/8/93
 /CONTACT: Kathleen Gary, 415-855-5924, or (after Sept. 8) Linda Thomas, 415-852-1321, both of Syntex; Don Tassone, 513-945-8170, or (after Sept. 8) Kris Burbank, 513-945-8066, both of Procter & Gamble/
 (SYN PG)


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

TM -- SJ002 -- 0049 09/08/93 18:33 EDT
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Publication:PR Newswire
Date:Sep 8, 1993
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