ABBOTT SEEKING .6% SELENIUM SULFIDE APPROVAL FOR OTC DANDRUFF

ABBOTT SEEKING .6% SELENIUM SULFIDE APPROVAL FOR OTC DANDRUFF and seborrheic dermatitis. In a July 29 submission to FDA, Abbott's Ross Labs subsidiary maintained that two clinical studies show no significant difference in efficacy or safety between .6% micronized selenium sulfide and 1% nonmicronized selenium sulfide, the active ingredient in the firm's Selsun Blue shampoo. Selenium sulfide 1% is currently listed in the Tentative Final Monograph for the category, which was published in the July 30, 1986 Federal Register. The deadline for new data was July 30 of this year; comments on the data are due Sept. 30. One six-week, double-blind study in 116 subjects compared .6% micronized selenium sulfide to 1% nonmicronized selenium sulfide and to a placebo control. Investigators reported that .6% micronized selenium sulfide is "statistically significantly more effective than shampoo vehicle and as effective as 1% nonmicronized selenium sulfide in treatment of dandruff symptoms," Ross said. The study was conducted by Research Testing Labs, Little Neck, N.Y. The second clinical, conducted by Dermatology Research, Los Angeles, compared Selsun Blue made with 1% nonmicronized selenium sulfide to that with 1% micronized selenium sulfide and a .6% micronized selenium sulfide version. "Results of this double-blind parallel study with 161 radomized subjects show that all three formulations substantially reduced dandruff, with no significant differences among the formulations," the firm told FDA. Two other clinicals "provide additional data on the safety of .6% micronized selenium sulfide," Ross said.