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Executive Summary

ORTHO's TERAZOL IS COMPARABLE, NOT SUPERIOR, TO MICONAZOLE, the company reported in a "Dear Prescriber" letter mailed in late February. The letter, sent to clarify earlier promotions, was mailed to 133,740 prescribers. Ortho states that FDA "data indicate that Terazol ]terconazole[ is not more effective than miconazole nitrate" and therefore "should be considered only as comparable to miconazole nitrate for the treatment of vulvovaginal candidiasis." FDA considered Terazol's introductory promotional material "to have employed 'best case' comparisons that were not representative of the overall body of available ]efficacy[ data," Ortho said. The agency felt that the campaign "may also have been interpreted as claiming that Terazol is safer and better tolerated than miconazole nitrate," the letter continues. "However, the overall incidence of side effects for the two products was comparable." FDA objected to the Terazol promotional material in a Nov. 16 regulatory letter. The agency said there was "no basis for" the campaign's claims of "superiority" of Ortho's Terazol to its Monistat antifungal product ("The Pink Sheet" Nov. 28, p. 9). Ortho pulled the ads in January, although a few were locked in for publication in February journals. With the "dear doctor" letter, FDA dropped an initial request for remedial advertising. Ortho's letter notes: FDA "requested that we contact you to correct possible misconceptions resulting from our recent introductory promotional campaign for Terazol (terconazole) Vaginal Cream and Vaginal Suppositories." The letter was mailed in envelopes stamped with the following bold-face type message in a wide brown border: "Important correction of drug information." The letter states that the promotion "presented comparisons which might be interpreted as claiming that Terazol is more effective than miconazole nitrate" and that it is "safer and better tolerated," Ortho said. "We regret any misconceptions about the relative efficacy and safety of these two products which our introductory promotional campaign may have caused."

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