Taro Receives Approval for Ammonium Lactate Cream, 12% ANDA.Business Editors/Health/Medical Writers HAWTHORNE, N.Y.--(BUSINESS WIRE)--April 10, 2003 Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS: 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 ammonium lactate Lactate A salt or ester of lactic acid (CH3CHOHCOOH). In lactates, the acidic hydrogen of the carboxyl group has been replaced by a metal or an organic radical. Lactates are optically active, with a chiral center at carbon 2. cream, 12%. Taro's ammonium lactate cream 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 Bristol-Myers Squibb's Lac-Hydrin(R) cream. Ammonium lactate cream is a prescription product used for the treatment of dry, scaly scal·y adj. 1. Covered or partially covered with scales. 2. Shedding scales or flakes; flaking. scaly skin condition characterized by scales; scalelike. skin (xerosis xerosis /xe·ro·sis/ (ze-ro´sis) abnormal dryness, as of the eye, skin, or mouth.xerot´ic xerosis generalisa´ta ) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions. According to industry sources, 2002 U.S. sales of ammonium lactate cream products were approximately $34.5 million. "Ammonium lactate cream gives physicians and patients an affordable option in treating skin disorders such as xerosis and ichthyosis vulgaris," said Barrie Levitt, M.D., Chairman of the Company. "This new product further enhances Taro's position as a leading supplier of topical dermatological products." Currently, Taro has 23 filings at the FDA: 21 ANDAs, including one tentative approval, one unique supplemental ANDA, and a New Drug Application related to the Company's NonSpil(TM) liquid drug delivery system. In addition, the Company has multiple regulatory filings in Canada, Israel and other countries around the world. 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. 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. Such forward- looking statements may include, but are not limited to, statements regarding production and marketing of Taro's ammonium lactate cream, 12%. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, marketplace acceptance of Taro's ammonium lactate cream, 12%, the future size of the market for this product, 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 2001 Annual Report on Form 20-F. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion