Taro Receives Tentative Approval for Terbinafine HCl Cream 1% ANDA; Generic Equivalent to Lamisil(R) Cream.HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. ("Taro," NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : TARO) reported today that its U.S. affiliate has received tentative 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 Terbinafine Hydrochloride terbinafine hydrochloride Desenex Max, Lamisil, Lamisil AT Pharmacologic class: Synthetic allylamine derivative Therapeutic class: Antifungal Pregnancy risk category B ActionCream 1% ("terbinafine cream").The FDA has determined that Taro's terbinafine cream is safe and effective for use when compared with the reference listed drug product, Lamisil(R) Cream of Novartis Consumer Health Inc. Terbinafine cream is an over-the-counter antifungal product which cures most 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. , jock itch and ringworm ringworm or tinea (tĭn`ēə), superficial eruption of the skin caused by a fungus, chiefly Microsporum, Trichophyton, or Epidermophyton. , and relieves the itching, cracking, burning and scaling which accompany these conditions. According to industry sources, Lamisil(R) Cream has annual U.S. sales in excess of $45 million. The tentative ANDA approval for terbinafine cream, which Taro believes is the first received by a company in the U.S., is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities, restrictions and any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission. The listed patent on Lamisil(R) Cream expires on December 30, 2006. Taro Pharmaceutical Industries Ltd. 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 terbinafine cream product. 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 consumer acceptance of the new Taro 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 Annual Reports 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. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion