Drug Regulation-Reply

In Reply.— Floraquin was introduced in 1936 based on data that were appropriate at the time. However, at the time of the more recent National Academy of Sciences and National Research Council reviews, Floraquin was classified as only possibly effective, due to the lack of well-controlled clinical studies supporting it. In view of the limited sales of Floraquin, Searle did not elect to undertake the clinical-trials program that would have been necessary to maintain it on the market. As a consequence, FDA approval of Floraquin was withdrawn and marketing was discontinued on July 7, 1975, with all supplies being recalled down to the retail level. The same FDA directive that caused the demise of Floraquin also caused a number of other topical preparations for the treatment of trichomonal vaginitis to be withdrawn from the market. The reasons for this directive were set forth in a letter from the FDA to