Taro Receives FDA Approval for Alclometasone Dipropionate Ointment USP, 0.05% ANDA; Generic Equivalent to Aclovate Ointment.HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that its U.S. affiliate has received approval 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. ") for 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 Alclometasone Dipropionate Ointment ointment /oint·ment/ (oint´ment) a semisolid preparation for external application to the skin or mucous membranes, usually containing a medicinal substance. oint·ment n. , USP USP - unique sales point 0.05% ("alclometasone ointment"). Taro's alclometasone ointment 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 GlaxoSmithKline's Aclovate(R) ointment, a low to medium 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 product. Alclometasone ointment, a prescription product, is used for the treatment of inflammatory skin diseases. U.S. sales of Aclovate(R) ointment were approximately $2.5 million in 2003, according to industry sources. Taro, a leader in topical dermatological products, manufactures and markets a wide range of prescription and over-the-counter creams, ointments and gels. Currently, Taro has 29 filings at the FDA: 28 ANDAs, including one tentative approval, plus a New Drug Application related to the Company's proprietary NonSpil(TM) liquid drug delivery system. In addition, the Company has regulatory filings in Canada, Israel and other countries. Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com. Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including statements regarding the Company's alclometasone ointment and other dermatology products. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's alclometasone ointment and other dermatology products; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its 2003 Annual Report on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise. |
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