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Executive Summary

SCHERING's GYNE-LOTRIMIN Rx-TO-OTC SWITCH APPROVAL APPEARS IMMINENT, which may give the clotrimazole product a headstart in the OTC vaginal antifungal market. Gyne-Lotrimin has been marketed since 1983 as a local treatment for vulvovaginal candidiasis and is available in a 1% cream, 100 mg tablets, and 500 mg tablets. The approval will mark the second Rx-to-OTC switch for a Schering clotrimazole-based product. In November 1989, FDA simultaneously approved prescription and OTC versions of Schering's Lotrimin AF for atheletes foot, jock itch and ringworm. The OTC market for candidiasis could be substantial. An estimated 23 mil. cases occur annually -- mostly repeat infections. The repetitive nature of the disease may facilitate the ability to self-diagnose the condition after first occurrence. In June, FDA's Fertility and Maternal Health Advisory Committee in June recommended approval of prescription vaginal fungicides for OTC use in the treatment of vulvovaginal candidiasis. Although FDA had proposed a discussion of clotrimazole and Ortho's miconazole (Monistat) for the meeting, the committee declined to consider specific prescription products ("The Pink Sheet" June 18, p. 3). With regard to labeling for these products, the committee essentially agreed with a presentation by Schering at the meeting, which suggested that labeling cite patients with the following attributes: short duration of onset of condition; mild to moderate symptom severity; four or less episodes of candidiasis in a 12-month period; reasonable degree of compliance with indicated treatment regiment; and low probability of another serious condition. Schering also recommended that OTC use be contraindicated for pregnant women. The advisory committee further agreed that OTC labeling should recommend against the use of vaginal antifungals in women who might have candidiasis for the first time or who suffer from chronic infections. An OTC approval for Gyne-Lotrimin would break FDA's long-held position against the category. In 1982, FDA's Antimicrobial II panel recommended the OTC use of haloprogin, miconazole, and nystatin in the treatment of external feminine itching and superficial skin infections associated with candidiasis. However, in its Antifungal Report, the agency said that it would not permit Rx-to-OTC switches for those products because of the health hazard of self-treatment of the symptoms associated with candidiasis without treating the underlying cause. Last year, FDA dropped nystatin from Category I to Category III in the Tentative Monograph for OTC Topical Antifungal Drug Products, saying that the treatment of superficial skin infections caused by yeast (Candida) is not an appropriate OTC claim. With the near-future OTC approval of clotrimazole, FDA appears to be more willing to approve Rx-to-OTC switches for these products through the NDA route rather than the monograph approach.

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