In Brief: Parsol 1789
This article was originally published in The Rose Sheet
Parsol 1789: Hoffmann-La Roche requests that FDA complete by Oct. 1 the necessary administrative functions that would allow for interim marketing of UVA sunscreen Parsol 1789 (avobenzone) in a May 21 letter. The letter responds to a May 9 letter from FDA stating that the agency will allow use of Parsol 1789 in combination with some Category I sunscreens and that interim marketing would be permitted only after a Federal Register notice and comment period process ("The Rose Sheet" June 3, p. 3). Hoffmann-La Roche additionally requested: interim marketing of Parsol 1789 combinations that have already been NDA-approved and have U.S. marketing experience; and an exemption from the IND regs for clinical testing of avobenzone combinations proposed for inclusion in the monograph...
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