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FDA APPROVES NAPROXEN SODIUM FOR NONPRESCRIPTION STATUS

 WASHINGTON, Jan. 11 /PRNewswire/ -- The Food and Drug Administration (FDA) today announced approval of naproxen sodium, a prescription arthritis drug, for marketing as a nonprescription pain reliever.
 Naproxen sodium is the second nonsteroidal analgesic product to win FDA approval for nonprescription pain relief. The first was ibuprofen, which has been on the market since 1984.
 Naproxen has been sold as a prescription drug under the trade name Naprosyn since 1976 and naproxen sodium under the trade name Anaprox since 1980.
 "Naproxen's long record of use clearly indicated that the drug could be sold over the counter, provided the manufacturer modified its dosage and labeling," said FDA Commissioner David A. Kessler, M.D. "We have made sure that the necessary safeguards are included in the nonprescription version of the product."
 In its over-the-counter version, naproxen sodium can be used to alleviate minor pain associated with headache, the common cold, toothache, muscle ache, backache, arthritis and menstrual cramps, and to reduce fever.
 In June 1993, two FDA advisory committees, meeting jointly, recommended against approving nonprescription status for naproxen sodium.
 Committee members were concerned that because the drug works slowly, consumers might become impatient and take too much. As with ibuprofen, naproxen sodium in excessive amounts can cause digestive problems such as heartburn and upset stomach. Committee members also were concerned about misuse of the drug by children and the elderly.
 Responding to these points, FDA asked the drug's manufacturer to lower the daily dosage, increase the recommended time between pills and add label warnings for children and for the elderly.
 Nonprescription naproxen sodium will be sold in tablets containing 200 mg naproxen and 20 mg sodium. For people age 12 to 65, the maximum daily dose is three tablets with eight to 12 hours between doses. People older than 65 should not take more than two tablets a day, or one every 12 hours. Children under 12 should not use naproxen sodium at all except under a doctor's supervision.
 Nonprescription naproxen sodium -- produced by Syntex Laboratories of Palo Alto, Calif., and distributed by Procter & Gamble Co. (NYSE: PG) of Cincinnati -- will be marketed under the trade name Aleve. FDA is one of eight Public Health service agencies within the U.S. Department of Health and Human Services.
 -0- 1/11/94
 /NOTE TO EDITORS: Attention TV Broadcasters: Please use open captioning for the hearing impaired./
 /CONTACT: June Wyman of the Food and Drug Administration, 301-443-3285, or, home, 301-495-9144/
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CO: Food and Drug Administration; Syntex Laboratories; Procter & Gamble
 Co. ST: District of Columbia IN: MTC SU: EXE


DC-KD -- DC017 -- 1021 01/11/94 13:25 EST
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Publication:PR Newswire
Date:Jan 11, 1994
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