Taro Receives Tentative Approval for Ciclopirox Topical Solution, 8% (Nail Lacquer) ANDA
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- Published on Wednesday, 28 March 2007 03:00
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HAWTHORNE, NY, USA | Mar 27, 2007 | 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”) for its Abbreviated New Drug Application (“ANDA”) 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 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 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 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 within the meaning of the Private Securities Litigation Reform Act 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.
SOURCE: Taro Pharmaceutical