Taro Pharmaceutical Industries announces FDA approval for Clobetasol Cream.HAWTHORNE, N.Y.--(BUSINESS WIRE)--July 9, 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 Applications (ANDAs) for Clobetasol Propionate clobetasol propionate (klōbā´t  sol´ prō´pē Cream USP USP - unique sales point , 0.05%. This high-potency topical corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and , commonly used in the short-term treatment of moderate to severe dermatologic conditions such as psoriasis, 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 Temovate Cream, 0.05%. The market in the United States for this prescription product is estimated by industry sources to be approximately $20 million. The approval of clobetasol cream represents Taro's second ANDA ANDA abbr. abbreviated new drug application approval of 1996. The company has already launched Desoximetasone Ointment USP, 0.25%, the ANDA approval of which was received in early June. The combined market for Desoximetasone Ointment USP, 0.25% and Desoximetasone Cream USP, 0.25% is estimated by industry sources to be in excess of $28 million. The company has multiple regulatory filings in Canada and Israel, and 10 ANDAs currently submitted to the FDA. Seven ANDAs are for dermatologic products, and three ANDAs are for solid dosage form central nervous system products. "Clobetasol cream is one of the largest-selling prescription topical corticosteroids Topical corticosteroids Cortisone and related drugs used on the skin and in the eye, usually for allergic conditions. Mentioned in: Corneal Ulcers . This approval further strengthens the company's dermatological product line," stated Barrie Levitt, M.D., chairman of the board of Taro Pharmaceutical Industries. "The company is hopeful that it will submit additional ANDAs to the FDA and will receive additional approvals in the second half of 1996." Taro Pharmaceutical Industries is a multinational pharmaceutical company whose research and development program has resulted in the company being the first generic marketer of several branded drugs as well as the developer of several novel pharmaceutical compounds. 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 800/PRO-INFO and enter company code 104 or ticker symbol TAROF. NOTE: Temovate is a registered trademark of Glaxo Wellcome Inc. CONTACT: Taro Pharmaceutical Industries Ltd., Hawthorne Peter Giallorenzo, 914/345-9001 or Financial Relations Board 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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