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

DATE: THURSDAY, June 3, 1993                   TAG: 9306030108
SECTION: NATL/INTL                    PAGE: A-6   EDITION: METRO 
SOURCE: 
DATELINE: ROCKVILLE, MD.                                LENGTH: Short

FDA PANEL REJECTS SALE OF DRUG OVER COUNTER

The most widely prescribed painkiller in its class of drugs should not be allowed for sale over the counter, a panel of experts told the government on Wednesday.

At least, not yet.

Naproxen, prescribed largely for arthritis and inflammation, has been available in the United States since 1976 and is sold in 92 other countries.

But a panel advising the Food and Drug Administration recommended against allowing its sale without a prescription in this country, saying the drug's makers failed to show the lower-strength, nonprescription formula is safe and effective.

Officials of Syntex Laboratories Inc., the manufacturer which markets the drug as Naprosyn, were bewildered.

After more than a day of arguments, the FDA's advisory committees on over-the-counter drugs and arthritis voted 7-4 against the application.

Dr. David Trentham, chairman of the joint committee meeting and one of those voting no, said the decision does not mean the drug is considered unsafe or worthless, only that the company did not bring enough new evidence to prove that the lower strength would work.

- Associated Press

by CNB