Taro Pharmaceutical Industries announces FDA approval for clobetasol ointment.HAWTHORNE, N.Y.--(BUSINESS WIRE)--July 16, 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 Clobetasol Propionate clobetasol propionate (klōbā´t  sol´ prō´pē Ointment 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 Ointment, 0.05%. The market in the United States for Clobetasol Propionate Ointment is estimated by industry sources to be approximately $16 million. The clobetasol ointment approval represents Taro's third ANDA approval of 1996. Earlier this month, the company received FDA approval for Clobetasol Propionate Cream USP, 0.05%, and in June 1996 the company received the first FDA generic approval for Desoximetasone Ointment USP, 0.05%. The combined market in the United States for these products is estimated by industry sources to be in excess of $40 million. "Taro's operating earnings will be enhanced during the second half of this year and into 1997 through our three ANDAs approved thus far this year," stated Barrie Levitt, M.D., chairman of the board of Taro Pharmaceutical Industries. "Further, we expect Taro's marketing operations will benefit from these additions to our full line of topical corticosteroid products, now recognized as one of the broadest in the generic pharmaceutical industry." The company has multiple regulatory filings in Canada and Israel, and nine ANDAs currently submitted to the FDA. Six ANDAs are for dermatologic products, and three ANDAs are for solid dosage form central nervous system products. 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. -0- 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 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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