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Ciba Tinosorb sunscreens

This article was originally published in The Rose Sheet

Executive Summary

Ciba Specialty Chemicals should initiate new drug application process for UVA/UVB filters Tinosorb M and Tinosorb S to obtain approval as OTC sunscreens, FDA says in July 15 letter to supplier. Letter denies Ciba's May 21 time and extent application to introduce ingredients in the U.S. based on foreign marketing experience. Ciba has "not demonstrated that the ingredients have been marketed for a material time and a material extent," FDA says, noting under its regulations, ingredients must be marketed for "a minimum of five continuous years in the same country and in sufficient quantity." Ciba sells the ingredients in more than five countries but could only provide two and a half years of continuous use data. TEA was adapted from citizen petition filed by the company Sept. 5, 2000 seeking monograph status for the ingredients (1"The Rose Sheet" Sept. 11, 2000, p. 9). FDA decision is apparently first refusal of TEA for sunscreen ingredients...

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