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Executive Summary

GIVAUDAN WILL FILE AN NDA FOR PARSOL 1789 SUNSCREEN INGREDIENT, Givaudan Corporate Counsel Robert Tavares told FDA in an Oct. 27 letter. Pending approval of the NDA, he said Givaudan would discontinue Parsol 1789 in the U.S. for use in consumer products. FDA told the company in an Oct. 6 reg letter that Parsol 1789 (butyl methoxydibenzoylmethane) could not be marketed without an approved NDA. "We intend, in the near future, to discuss with the Center for Drugs and Biologics appropriate steps we can take to obtain FDA approval for use of Parsol 1789 as an OTC drug sunscreen ingredient in a wide variety of consumer products," Tavares told FDA Center for Drugs and Biologics Office of Compliance Director Daniel Michels. He said Givaudan is advising its customers by telephone and mail of its decision to discontinue the product. The Clifton, N.J.-based affiliate of Geneva-based Givaudan estimates that over 40 mil. units containing Parsol 1789 have been sold in Europe, Australia and other parts of the world since its introduction in 1981. The product was introduced in the U.S. in 1984. Estee Lauder and Clarins previously marketed sunscreen products containing butyl methoxydibenzoylmethane but opted to reformulate them after receiving similar reg letters from FDA. Estee Lauder agreed to eliminate both butyl methoxydibenzoylmethane and propyl methoxycinnamate from its Estee Lauder Sun and Prescriptives products in June ("The Pink Sheet" June 30, T&G-3) and Clarins dropped the Parsol 1789 ingredient in June 1985. A scientific exhibit on Parsol 1789 will be presented at the American Academy of Dermatology's annual meeting in New Orleans Dec. 6-11. The exhibit will include a study on topical protection against UVA and UVB radiation conducted by researchers at Herbert Labs, Harvard Medical School and UCLA. Herbert Labs does not currently market any sun care products.

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