Regulatory In Brief
This article was originally published in The Rose Sheet
Executive Summary
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)...
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Sunscreen ingredient
BASF seeks 90-day extension to respond to FDA request for data on octyl triazone sunscreen; previous deadline was Oct. 9. BASF maintains it needs more time to compile recent effectiveness data and that extension would allow for a " more comprehensive and complete docket" on the substance. Beiersdorf submits letter to FDA Oct. 7 in support of BASF's time and extent application for ingredient, noting German firm has used octyl triazone in its own sun care products outside the U.S. for more than five years without "unusual adverse event experience." FDA requested data on the ingredient in a July 11 Federal Register notice (1"The Rose Sheet" July 14, 2003, Regulatory In Brief)...
Sunscreen ingredient
BASF seeks 90-day extension to respond to FDA request for data on octyl triazone sunscreen; previous deadline was Oct. 9. BASF maintains it needs more time to compile recent effectiveness data and that extension would allow for a " more comprehensive and complete docket" on the substance. Beiersdorf submits letter to FDA Oct. 7 in support of BASF's time and extent application for ingredient, noting German firm has used octyl triazone in its own sun care products outside the U.S. for more than five years without "unusual adverse event experience." FDA requested data on the ingredient in a July 11 Federal Register notice (1"The Rose Sheet" July 14, 2003, Regulatory In Brief)...
Octyl Triazone Sales Of 400 Mil. Sunscreen Units Abroad Cited By FDA
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