REPEAT/Taro Pharmaceutical Industries announces FDA approval for clotrimazole solution; fourth ANDA approval of 1996.HAWTHORNE, N.Y.--(BUSINESS WIRE)--July 30, 1996--Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS:TAROF) Tuesday reported its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Taro Pharmaceuticals Inc., of Ontario, Canada, has received notification from the U.S. Food and Drug Administration ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") approving its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA abbr. abbreviated new drug application ") for both prescription and over-the-counter ("OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ") Clotrimazole clotrimazole /clo·trim·a·zole/ (klo-trim´ah-zol) an imidazole derivative used as a broad-spectrum antifungal agent. clo·trim·a·zole n. Solution USP USP - unique sales point , 1%. This topical antifungal, commonly used in the treatment of conditions such as athlete's foot athlete's foot: see ringworm. athlete's foot Form of ringworm that affects the feet. In the inflammatory type, the infection may lie inactive much of the time, with occasional acute episodes in which blisters develop, mostly between the toes. , is bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Lotrimin (a) Solution. The market in the United States for both prescription and OTC clotrimazole solution is estimated by industry sources to be approximately $6 million. The approval for clotrimazole solution is Taro's third ANDA approval in July 1996, and the fourth ANDA approval this year. Earlier this year the Company received ANDA approvals from the FDA for Clobetasol Propionate Cream USP, 0.05%, Clobetasol Propionate Ointment USP, 0.05% and the first FDA generic approval for Desoximetasone Ointment USP, 0.25%. "Our significant investment in research and development is paying off," stated Barrie Levitt M.D., Chairman of Taro Pharmaceutical Industries. "We are seeing the initial results of this investment and will maintain an aggressive development program, which is the key to Taro's continued growth." The company now has a wide range of clotrimazole products. In 1993 Taro received the first generic FDA approval for prescription and OTC Clotrimazole Cream USP, 1%, a topical antifungal also used in the treatment of athlete's foot. In December 1995 Taro received FDA approval for Clotrimazole Vaginal Cream USP, 1%, an OTC treatment for vaginal yeast infections. The clotrimazole solution approval fills out the company's line of clotrimazole products. The company has multiple regulatory filings in Canada and Israel, and eight ANDAs currently submitted to the FDA. Five ANDAs are for dermatologic products, and three ANDAs are for solid dosage form central nervous system products. Taro Pharmaceutical Industries, a growth-oriented manufacturer/marketer of prescription and OTC generic drug products, is well-positioned to take advantage of worldwide generic drug growth and the company's development of several novel pharmaceutical compounds. Taro's extensive research and development expertise, broad distribution network and vertical integration capabilities fuel the company's expansion in domestic and international pharmaceutical markets. For further information on Taro Pharmaceutical Industries, please visit the company's home page at http://www.taropharma.com. To receive additional information on Taro, via fax at no charge, dial 1-800-PRO-INFO and enter company code 104 or ticker symbol TAROF. (a) Lotrimin is a registered trademark of Schering Plough Healthcare Products Inc. CONTACT: Taro Pharmaceutical Industries Peter Giallorenzo, 914/345-9001 or The Financial Relations Board Inc. Daniel Saks, 310/442-0599 (general info) Kate Rajeck, 312/266-7800 (analyst info) Steven Seiler, 310/442-0599 (media info) |
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