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FDA Warns Galderma Over Visual Aids

September 4, 2009
Galderma Laboratories overstated the efficacy of its Tri-Luma cream for the skin condition melasma in visual aids and minimized important risks, according to an Aug. 18 warning letter posted recently to the FDA’s website. The agency’s Division of Drug Marketing, Advertising and Communications reviewed two professional visual aids for Tri-Luma (fluocinolone acetonide/hydroquinone/tretinoin), which is indicated for the treatment of moderate-to-severe melasma, or hyperpigmentation, of the face when a patient is avoiding sun exposure and using sunscreens. The visual aids were disseminated with unapproved product labeling that also included false and misleading claims, according to the letter.
Washington Drug Letter