GIVAUDAN SEEKING EXPEDITED FDA APPROVAL FOR PARSOL 1789
• By The Pink Sheet
GIVAUDAN SEEKING EXPEDITED FDA APPROVAL FOR PARSOL 1789 in varying finished product formulations. Givaudan said it recently began negotiating with FDA for a procedure to shorten the approval process for Parsol 1789 (butyl methoxydibenzoylmethane) formulation changes. "Givaudan has, through its attorney, begun discussions with the FDA in order to attempt to find an acceptable method which would allow its customers to make formulation changes without going through the full NDA process every time they wish to do so," Corporate Counsel Robert Tavares stated in a letter to "F-D-C Reports." Givaudan plans to file NDAs for a limited number of Parsol 1789 formulations which could be used as the basis for the expedited approval of other formulations of the sunscreen ingredient. "Since Givaudan will not be able to obtain approval of an NDA based on Parsol 1789 per se, it will file an NDA on particular formulations for the main purpose of providing additional information to our customers," the company said. The firm noted that there is "no mechanism presently available that would allow Givaudan to get the kind of FDA approval that exists for ingredients on the OTC monograph, i.e. the kind of approval that would let the Parsol 1789 customer introduce the compound into its formulation without prior FDA approval for that particular formulation." Parsol 1789 is a UV-A absorber which must be used with a UV-B sunscreen for broad spectrum sunscreen protection, Tavares pointed out. Therefore, "if each manufacturer wishes to provide a line of products using its own unique formulations containing Parsol 1789, and wishes to be free to use any of a number of the available approved active ingredients in combination with the Parsol 1789, it is clear that the NDAs required to cover all these products will be innumerable and will constitute a burden for both the industry and the FDA if they are indeed filed." FDA told Givaudan last October that butyl methoxydibenzoylmethane is an unapproved drug. The firm subsequently said it would stop marketing the sunscreen until had obtained an approved NDA ("The Pink Sheet" Nov. 10, T&G-11). Germaine Monteil, Alfin, Orlane and Shiseido were recently cited by FDA for using the unapproved sunscreen in a variety of skin renewal products. Estee Lauder and Clarins received reg letters in 1985 for their use of Parsol 1789 in sun care products and have agreed to reformulate. To date, at least one company has filed an NDA for Parsol 1789. Allergan filed an NDA for the ingredient in 1984 and has an agreement with Givaudan to develop its own version of Parsol 1789. Allergan's Herbert Labs division recently conducted an outdoor study on the ingredient which the company said confirmed previous studies that Parsol 1789 was an effective UV-A blocker and an effective broad spectrum sunscreen when used in combination with padimate-0 ("The Pink Sheet" March 23, T&G-8).
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