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PARSOL 1789 GRAS/E STATUS NOT IMPEDED BY SHADE OVAGUARD NDA, GIVAUDAN-ROURE

This article was originally published in The Tan Sheet

Executive Summary

PARSOL 1789 GRAS/E STATUS NOT IMPEDED BY SHADE OVAGUARD NDA, GIVAUDAN-ROURE counsel Edward Basile of the Washington, D.C. law firm King & Spalding asserted in an April 26 letter to FDA. Addressing comments made by Shade UVAGuard marketer Schering- Plough to FDA on March 17 ("The Tan Sheet" April 11, p. 10), Basile said Givaudan-Roure was "surprised" that Schering would suggest "that the avobenzone we supply to Schering-Plough under the tradename Parsol 1789 has not been sufficiently reviewed by the agency to establish its status as a generally recognized as safe and effective ingredient."
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