
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: WEDNESDAY, January 12, 1994                   TAG: 9401120129
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-2   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Short

FDA APPROVES SALE OF NEW PAIN RELIEVER

For the first time in a decade, the Food and Drug Administration has approved marketing of an over-the-counter pain reliever containing a new analgesic ingredient.

The FDA on Tuesday approved naproxen sodium for nonprescription sale as a pain reliever. The drug previously had been available only as a prescription arthritis drug and has been marketed since 1976 under the trade name Naprosyn.

Naproxen sodium in its nonprescription form will be manufactured by Syntex Laboratories of Palo Alto, Calif., and marketed by Procter & Gamble Co. of Cincinnati under the trade name Aleve.

The last nonprescription pain reliever based on a new analgesic ingredient was ibuprofen, which was approved by the FDA for over-the-counter sales in 1984.

In its nonprescription form, naproxen sodium is approved for the relief of minor pain associated with headache, toothache, muscle ache, backache, the common cold, arthritis and menstrual cramps; and to reduce fever.

FDA advisory committees, meeting jointly in June, recommended against approving naproxen sodium for nonprescription use. The committees were concerned that consumers would overdose on the drug. There also was concern about misuse of the drug by children and the elderly.

In response, the FDA asked the manufacturer to reduce the daily dose, extend the time between doses and add label warnings for children and for the elderly.

Labeling for the new over-the-counter drug calls for the pills to be taken eight to 12 hours apart, with no more than three to be taken daily.

by CNB