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Executive Summary

NEOMYCIN/CORTICOSTEROID DERMATOLOGIC COMBOS ARE DESI EFFECTIVE, FDA declared in a March 28 Federal Register notice. The agency explained that in 1981 it concluded that the products lacked adequate evidence of effectiveness, but that it has since reevaluated the data existing then, plus new evidence, and is now reclassifying the combos as effective "for the treatment of corticosteroid-responsive dermatoses with secondary infection." FDA stipulated that the labeling for the products state that: "It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after seven days of treatment." Under the "Warnings" section of the labeling, FDA declared that the following statement must appear: "Because of concern of nephrotoxicity and ototoxicity associated with neomycin, this combination product should not be used over a wide area or for extended periods of time." The notice clears the way for the continued marketing of 14 separate products identified in the notice by the agency, plus other identical products. However, supplemental NDAs or ANDAs containing the required labeling must be submitted to the agency by May 29, 1984, the notice said. FDA explained that after it originally concluded that the combos lacked evidence of effectiveness, it received two studies with Syntex' Neo-Synalar (neomycin sulfate and fluocinolone acetonide). The agency said that the two studies "provided substantial evidence of the combination, showing that each component contributes to the beneficial effect in patients with corticosteroid-responsive dermatoses with secondary infection." The notice said that the reclassification was also influenced by comments received from the American Academy of Dermatology stating "that the clinical benefit from these products would be expected to be greatest during the early phase of treatment." The notice also said that the agency "has determined that this finding of effectiveness" from the Neo-Synalar studies "should not be limited to neomycin in combination with one, specific corticosteroid because there is no corticosteroid that is unique with respect to therapeutic and toxic effects. . . Therefore [FDA] considers the two adequate and well-controlled studies [with Neo-Synalar] to provide substantial evidence of effectiveness for the other products listed, each of which is an ointment, cream or lotion that contains neomycin with an effective corticosteroid." Chart omitted.

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