Taro Receives Tentative Approval for Ciclopirox Topical Solution, 8% (Nail Lacquer) ANDA.Generic Equivalent to Penlac[R] Nail Lacquer lacquer, solution of film-forming materials, natural or synthetic, usually applied as an ornamental or protective coating. Quick-drying synthetic lacquers are used to coat automobiles, furniture, textiles, paper, and metalware. Topical Solution, 8% HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. ("Taro," Pink Sheets: TAROF) reported today that it 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 Ciclopirox Topical Solution, 8% (Nail Lacquer) ("ciclopirox nail lacquer"). Ciclopirox nail lacquer is a prescription pharmaceutical product used for the topical treatment of fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. of the fingernails and toenails ("onychomycosis"). The FDA has determined that Taro's ciclopirox nail lacquer is safe and effective for use when compared with the reference listed drug product, Penlac[R] Nail Lacquer (ciclopirox) Topical Solution, 8%, of Sanofi-Aventis Pharmaceuticals U.S. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. industry sources, Penlac[R] Nail Lacquer has annual U.S. sales of approximately $88 million. Taro manufactures and markets a broad line of prescription and over-the-counter antifungal antifungal /an·ti·fun·gal/ (-fung´gal) 1. destructive to fungi, or suppressing their reproduction or growth; effective against fungal infections. 2. an agent that so acts. products. The tentative ANDA approval for Taro's ciclopirox nail lacquer 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 and restrictions (currently expected to occur during September 2007), or 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. 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, please visit www.taro.com. Certain statements in this release are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 ciclopirox nail lacquer and other antifungal 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 failure to receive final approval for Taro's ANDA submission for ciclopirox nail lacquer; the granting of additional exclusivities or restrictions to Penlac[R] Nail Lacquer; industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's ciclopirox nail lacquer and other antifungal 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. |
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