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Executive Summary

GIVAUDAN PLANNING FIVE (NDAs) FOR PARSOL 1789 SUNSCREEN in November, according to the ingredient supplier. The five NDAs are for finished OTC sunscreen formulations containing Givaudan's patented UVA-absorbing ingredient Parasol 1789 (butyl methoxydibenzoylmethane). Two of the formulations would have sun protection factors of 10. They also contain Givaudan's Parsol MCX (octyl methoxycinnamate), a Category I UVB-ray blocking ingredient. The five formulas contain Parsol 1789 at a concentration of 3%, which is the same strength used in Herbert Labs' Photoplex, the first Parsol 1789 product to receive an approved NDA ("The Pink Sheet" Oct. 10, T&G-5). Givaudan, a subsidiary of Roche, began negotiations with FDA last year to design and expedited process for other marketers to seek approval. The company would like to develop a method of approval in order to alleviate the need for FDA to review large numbers of similar NDAs for products formulated with Parsol 1789 and other active sunscreen ingredients, or for inert ingredient modifications. The Parsol situation provides a good example of the regulatory logjam of OTC applications that FDA will face in the post-monograph period. As the process now exists, Givaudan will hold NDAs, and product marketers will be restricted to licensing those formulations. To introduce new formulations, marketers would be required to file subsequent NDAs or convince FDA to accept some form of ANDA petition process.

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