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TARO PHARMACEUTICALS RECEIVES FIRST ANDA APPROVAL FOR TOPICAL CLOTRIMAZOLE

This article was originally published in The Tan Sheet

Executive Summary

TARO PHARMACEUTICALS RECEIVES FIRST ANDA APPROVAL FOR TOPICAL CLOTRIMAZOLE cream 1% on Aug. 31. Clotrimzaole cream 1% is the generic equivalent of Schering-Plough's prescription Lotrimin and OTC Lotrimin AF antifungal products. The company initially filed the ANDA in 1988. Taro said it "expects to begin marketing both the OTC and prescription versions of the product in the fourth quarter of 1993." Taro estimated that Schering's Lotrimin products, which are marketed for athlete's foot, jock itch and ringworm, generate annual sales of approximately $ 40 mil. in the U.S., split almost evenly between OTC and Rx product lines. Clotrimazole cream represents Taro Pharmaceuticals' first approval of a major OTC private label product. The company said it currently is exploring whether to license the product to a private label packager or do its own marketing of clotrimazole private label products to retailers. In addition, the company manufactures a number of topical OTC ingredients, including hydrocortisone .5% and 1% creams and ointments, tolnaftate 1% cream, and miconazole nitrate 2% cream. Taro Pharmaceuticals is a subsidiary of Israeli generic drug firm Taro Vit.
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