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News 01/11/1994

P94-1                                Food and Drug Administration
FOR IMMEDIATE RELEASE                June Wyman (301) 443-3285
     The Food and Drug Administration 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.
                             -MORE-
ATTENTION TV BROADCASTERS:  PLEASE USE OPEN CAPTIONING FOR THE
                            HEARING IMPAIRED.
                                      Page 2, P94-1, Naproxen
     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 8 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. of Cincinnati, Ohio -- will be marketed under the trade
name Aleve.    FDA is one of eight Public Health Service agencies
within HHS.
                              ####

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