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Executive Summary

Miles is adding a new indication and dosage form of its Rx-to- OTC switch drug, clotrimazole. Supplemental NDAs for Mycelex-7 (clotrimazole) 100 mg tablet and 1% cream were approved for treatment of vaginal candidiasis on Dec. 26. Mycelex-7 is the third prescription treatment for yeast infections to go over-the-counter in a little more than a year. Schering-Plough gained OTC approval on Nov. 30, 1990 for its clotrimazole product Gyne-Lotrimin, which is available as a 1% cream and 100 mg vaginal tabs. Ortho followed suit with a Feb. 15, 1991 approval for Monistat 7 (miconazole) in 2% cream and 100 mg vaginal inserts. Both Gyne-Lotrimin and Monistat have been extensively promoted to consumers in print and TV ads and have had strong first-year sales. OTC Gyne-Lotrimin sales, for example, topped $100 mil. in 1991. Miles has not disclosed marketing or pricing plans for Mycelex-7. Miles first received approval to market 1% clotrimazole OTC as a treatment for ringworm, jock itch and athlete's foot on April 1, 1991. The firm submitted a supplemental NDA in the autumn of 1990 for OTC Mycelex in cream and liquid forms. The company markets prescription clotrimazole as Mycelex-G in 100 mg and 500 mg vaginal tablets and a 1% vaginal cream. Bristol-Myers Squibb's Mead Johnson Labs is promoting the advantages of a single-dose prescription drug compared to OTCs for the treatment of vulvovaginal yeast infections with the introduction of Vagistat-1 (tioconazole 6.5%). The OTCs are used in a seven-day treatment course. Mead Johnson said that Vagistat-1's recommended retail price of $24.07 is sometimes less expensive than OTC antifungals and noted that, unlike the OTC products, the consumer cost for Vagistat-1 is usually covered by health plans. Mead Johnson also is emphasizing the convenience of Vagistat-1 as "the only one-dose ointment for vaginal yeast infections." The product consists of a pre-filled applicator with approximately 4.6 grams of ointment containing 300 mg of tioconazole. Ads for Vagistat-1 will run in ob/gyn journals. Bristol-Myers Squibb licensed the drug from Fujisawa Pharmaceutical, which had marketed the product under the tradename Vagistat since October 1989. Fujisawa obtained the U.S. marketing rights to the antifungal from Pfizer in May 1989.

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