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Sunscreen petitions

This article was originally published in The Rose Sheet

Executive Summary

FDA will "give priority" to reviews of time and extent applications (TEAs) submitted by firms that previously petitioned agency to include specific foreign-marketed ingredients in sunscreen monograph, FDA reiterates in six letters to ingredient suppliers and their counsel. As outlined in Jan. 23 final reg, citizen petitions must be converted to TEAs "within 120 days" of rule's publication (1"The Rose Sheet" Jan. 28, 2002, p. 9). Letters to Ciba Specialty Chemicals, EM Industries, BASF counsel and Haarmann & Reimer counsel, dated from April 19 through April 25, advise firms that agency does not "intend to take further action" on firms' respective petitions...

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Extended TEA deadlines

FDA grants 90-day extension, until Aug. 21, for submitting for priority review "time and extent" applications based on previously filed citizen petitions to include foreign-marketed ingredients in OTC monographs. Agency's June 20 letters to various firms recognize several factors limiting companies' ability to complete applications by original May 23 deadline, including age of original petitions, foreign locations of parent companies. Merck KGaA, BASF, P&G, European-American Phytomedicines Coalition among petitioners notified about extension; ingredients at issue include sunscreens, antiseptics, ginger, valerian. Agency originally had directed petitions be converted to TEAs within 120 days of Jan. 23 final reg on "material time, material extent" criteria (1"The Rose Sheet" May 6, 2002, In Brief)...

Merck TEA request

Merck KGaA U.S. affiliate EM Industries seeks 90-day extension to convert pending citizen petition for sunscreen ingredient Eusolex 6300 into "time and extent application" for priority review. In May 21 letter to FDA, Merck counsel Buchanan Ingersoll (Washington, D.C.) says company expects to file TEA but "due to the extensive lapse of time" since petition's filing in 1980, recompiling original data "and supplementing that information with data and other relevant information generated over the last 20 years has been difficult." In April, FDA notified petitioners they have 120 days from Jan. 23 publication of "material time, material extent" rule to convert petitions into TEAs (1"The Rose Sheet" May 6, 2002, In Brief). Merck says it would consider any denial of additional time, coupled with agency's April letter, to be a "final administrative action" on the petition and would "seek relief through the judicial system"...

OTC “Time & Extent” Requirements Reduced For Extensively Marketed Drugs

Sponsors of OTC drugs with extensive foreign marketing experience need not provide detailed information from each country in requesting the drug or "condition" be considered for OTC monograph eligibility in the U.S., FDA says

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