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SCHERING LOTRIMIN A.S WILL BE FIRST OTC SIMULTANEOUSLY MARKETED

Executive Summary

SCHERING LOTRIMIN A.S WILL BE FIRST OTC SIMULTANEOUSLY MARKETED in exactly the same dosage form and strength as a prescription version. FDA approved an Rx-to-OTC switch for three of five indications for the clotrimazole 1% product on Oct. 27: tinea pedis (athletes foot); tinea cruris (jock itch); and tinea corporis (ringworm). Schering will continue to market clotrimazole 1% as a prescription product for candidiasis and tinea versicolor. The OTC approval marks the end of over a year of discussion between Schering and FDA about the status of clotrimazole and the beginning of a new FDA policy on simultaneous prescription and OTC marketing. FDA announced in May that it will allow prescription and OTC marketing of the same product in the same dosage form and strength on a case-by-case basis ("The Pink Sheet" May 22, p. 3). Schering's supplemental NDA to move the three clotrimazole indications OTC, and the ensuing regulatory disagreement, was presumably the impetus for FDA's policy shift. After submitting the supplemental NDA in December 1987, the company was reportedly told by FDA that Lotrimin could not be marketed both Rx and OTC. FDA reportedly suggested that the product be marketed as an OTC, with the prescription uses handled in professional labeling. Schering's outside legal counsel, D.C. lawyer Peter Barton Hutt (Covington & Burling), questioned the legality of FDA's decision in a June 1988 petition to the agency ("The Pink Sheet" Jan. 9, 1989, T&G-6). * In announcing the Rx/OTC policy in May, FDA Associate Chief Counsel for Drugs David Adams said that different brandnames would be one of the agency's criteria for allowing simultaneous marketing. The closely related names for the OTC and prescription clotrimazole products, however, indicates that FDA may only require slight modifications to prescription tradenames. That policy could be important for a number of upcoming switches, such as ulcer drugs, where there is high brand recognition. The policy is particularly noteworthy for Schering and Marion, which have begun a campaign to reinforce the Carafate trade name prior to its anticipated OTC switch.
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