Octyl Triazone Sales Of 400 Mil. Sunscreen Units Abroad Cited By FDA
This article was originally published in The Rose Sheet
Executive Summary
Based on bulk material sales, nearly 400 mil. sunscreen dosage units containing octyl triazone have been sold in 35 countries, FDA notes in an evaluation of BASF's time and extent application for including the ingredient in the OTC sunscreen monograph
You may also be interested in...
FDA on TEA confidentiality
Agency will not keep confidential information that is necessary to meet the "material time" and "material extent" requirements of a Time and Extent Application, FDA says in letters to Merck KgaA, BASF and Symrise regarding the firms' respective requests to include enzacamene, octyl triazone and amiloxate in the OTC sunscreen monograph. For example, while FDA agrees to omit some information from each submission prior to putting it on public display, the agency tells BASF that information regarding specific sales, use and pricing data for select countries will not be redacted. The letters respond to specific requests made by each of the companies. FDA released its evaluation of the three TEAs earlier this year (1"The Rose Sheet" July 28, 2003, p. 11). The ingredients are among the first to be announced as eligible for monograph inclusion via the TEA process...
FDA on TEA confidentiality
Agency will not keep confidential information that is necessary to meet the "material time" and "material extent" requirements of a Time and Extent Application, FDA says in letters to Merck KgaA, BASF and Symrise regarding the firms' respective requests to include enzacamene, octyl triazone and amiloxate in the OTC sunscreen monograph. For example, while FDA agrees to omit some information from each submission prior to putting it on public display, the agency tells BASF that information regarding specific sales, use and pricing data for select countries will not be redacted. The letters respond to specific requests made by each of the companies. FDA released its evaluation of the three TEAs earlier this year (1"The Rose Sheet" July 28, 2003, p. 11). The ingredients are among the first to be announced as eligible for monograph inclusion via the TEA process...
Regulatory In Brief
Wella buy gets green light: Federal Trade Commission grants regulatory approval to Procter & Gamble to proceed with its planned acquisition of German beauty firm Wella. P&G continues to pursue necessary regulatory and governmental approvals in other major markets including the EU, firm notes. P&G owns 79.17% of total registered share capital and about 84.9% of the value of outstanding shares of Wella following the close of the second and final tender period in June (1"The Rose Sheet" June 30, 2003, Finance In Brief)...