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GIVAUDAN-ROURE PARSOL 1789 CITIZEN's PETITION BASED ON U.S. DATA

This article was originally published in The Tan Sheet

Executive Summary

GIVAUDAN-ROURE PARSOL 1789 CITIZEN's PETITION BASED ON U.S. DATA requests that FDA reopen the administrative record to include the broad spectrum UVA filter, also known as avobenzone, as an active ingredient in the sunscreen tentative final monograph. The March 2 petition also asks that FDA permit the marketing of "broad-spectrum combination" sunscreen products containing Parsol 1789 "in a range of SPF values," and that companies be permitted to market the combination products in the interim pursuant to a determination on the safety and effectiveness of the ingredient and the combination products in the final monograph. Parsol 1789 has been marketed in the U.S. for four years under an approved NDA as the active ingredient in Herbert Labs' Photoplex. FDA commented that the March 2 petition will not be addressed in the tentative final monograph; however, the agency could respond in an amendment to the TFM or in the final monograph. FDA said it expects to publish the sunscreen TFM in a "couple of months." Givaudan's petition relies primarily on U.S. test and marketing data to demonstrate that Parsol 1789 is generally recognized as safe and effective in the U.S. as a UVA sunscreen ingredient. In an October 1990 petition to the agency, Givaudan- Roure asked FDA to consider Parsol 1789 for inclusion in the TFM based on foreign testing and marketing data. "Although the 1990 petition for Parsol 1789 is still pending before FDA, Givaudan-Roure understands that FDA is reluctant to reopen the record and consider Parsol 1789, or any other ingredient not reviewed by the [Advisory Review Panel for Over- the-Counter (OTC) Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and Treatment Products], based solely or primarily on foreign data," the March 2 petition states. Givaudan also was a participant in a July 1990 joint citizen's petition by European sunscreen manufacturers, including E. Merck, Haarman & Reimer and L'Oreal, that urged FDA to reopen the sunscreen monograph to consider ingredients made outside the U.S. FDA responded to Givaudan at a Nov. 9, 1992 feedback meeting, stating that "timing" will not allow FDA to respond to the 1990 petitions in the sunscreen TFM. Givaudan-Roure noted in the petition that over 5.5 mil. units of Photoplex have been sold in the U.S., containing more than 19 metric tons of Parsol 1789. The company also cited the Dec. 9, 1992 approval of an NDA for Schering-Plough's Shade UVAguard, which contains 3% avobenzone, 3% oxybenzone and 7.5% octyl methoxycinnamate. Photoplex contains 3% avobenzone and 7% padimate O. "The adverse drug experience reports made for Photoplex during the last four years mainly reflect a minimal incidence of mainly topical allergic reactions," the petition argues. "Published European studies report only isolated instances of topical allergic reactions to Parsol 1789." The ingredient has been marketed for 11 years overseas, during which more than 725 metric tons have been sold, representing over 350 mil. units of pharmaceutical and cosmetic products sold. "None of the study subjects in the published [clinical] trials were reported to have experienced adverse reactions to Parsol 1789 alone or in combination with padimate O (a UVB screen)," the petition notes. Givaudan-Roure's petition lists acute toxicity, sub-chronic toxicity, in vitro and in vivo mutagenicity, in vitro photomutagenicity, animal studies and human clinical studies. "Additional, corroborative evidence" named in the petition is Givaudan-Roure's drug master file of information and data reviewed by FDA in connection with the NDAs for Photoplex and Shade UVAguard. Givaudan-Roure "understands that FDA has expressed some concerns about the labeling for combination products containing Parsol 1789," the petition notes. The firm said it will accept the labeling in Herbert Labs' NDA for Photoplex, which claims "Broad- Spectrum Sunscreen Lotion," "Absorbs Throughout the UVA Spectrum," and "Photoplex Broad-Spectrum Sunscreen Lotion provides protection from acute and long-term risks associated with UVA and UVB light exposure."

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