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Executive Summary

TARO WILL BEGIN SHIPPING FIRST GENERIC VERSION OF TOPICORT (desoximetasone) by Jan. 15, the generic firm said. Taro Pharmaceuticals' desoximetasone 0.05% and 0.25% cream was approved by FDA on Nov. 30. The topical corticosteroid will be "AB-rated" (therapeutically equivalent) to the brandname product, Hoechst-Roussel's Topicort, FDA indicated. Taro's desoximetasone will be available at a price to wholesalers of $6.05 for the 0.25% cream in a 15 gm tube and$14.69 for a 60 gm tube. The price to wholesalers for the 0.05% cream will be $4.60 for a 15 gm tube and $11.19 for a 60 gm tube. Taro said that its product will be 20% less than the brandname product's average wholesale price. The company plans to run an ad announcing the availability of the product in the January issues of Drug Topics and Drug Store News. Mailings will also be sent out to wholesalers and chain drug stores. Taro filed its ANDA for desoximetasone cream in March 1989. To gain approval, the drug underwent vasoconstrictor tests, a standard equivalence test for generic nonsystemically absorbed drugs. The corticosteroid is used for dermatological ailments. The labeling for Topicort states that it is indicated for "the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses." Taro Pharmaceuticals, U.S.A., headquartered in Hawthorne, N.Y., is the U.S. subsidiary of Taro-Vit, an Israel-based company. In 1984, Taro gained the first generic approval of another topical corticosteroid, fluocinonide (Syntex' Lidex).

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