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Executive Summary

CLOTRIMAZOLE ANDAs: FDA IS LEANING TOWARD CLINICAL STUDY in 60-patients to show comparative efficacy with the reference product as a requirement for ANDA approval. The study protocol for generic clotrimazole creams, lotions and vaginal tablets would include the reference product as an active control, the generic version and small placebo group. FDA may require, however, only in vitro studies for clotrimazole in the solution form. FDA met Feb. 22 to discuss approval criteria for the agent in anticipation of the branded products' upcoming patent expiration date on December 5, 1989. Clotrimazole is currently marketed by both Schering-Plough and Miles in several topical formulations under the Lotrimin and Mycelex brands, respectively. Under a topical antifungal guidance issued May 1988, FDA recommended that firms considering an ANDA submission submit bioequivalence testing with clinical endpoints for all dosage formulations against dermatophytes, Tinea versicolor and candidiasis. However, the agency now anticipates issuing a revised guidance. FDA is considering requiring similar approval criteria for topical formulations of miconazole, an antifungal marketed by Ortho as Monistat, due to come off patent October 1, 1991. At least one generic company is interested in pursuing an antifungal ANDA and attended the Feb. 22 FDA meeting. To date, no generic applications have been approved for post-1962 topical antifungals.

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