OTC naproxen
Executive Summary
Syntex participated in a closed meeting of FDA's Arthritis Drugs Advisory Committee May 24-25 to discuss what the committee and FDA would like to seek from companies planning to seek Rx-to-OTC switches for nonsteroidal anti-inflammatory agents, the company told securities analysts July 19. Syntex said that it has not yet submitted an NDA for OTC naproxen, which is being developed under a joint venture with Procter & Gamble. Syntex characterized the meeting as "favorable" and said that the Syntex/P&G joint venture is "on track" to introduce OTC naproxen in the U.S. before the product's patent expires in December 1993.
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