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Taro Receives FDA Approvals for Ciclopirox Topical Solution, 8% (Nail Lacquer) and Grape Flavor Formulation of Loratadine Syrup, 5mg |
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21 Sep 2007 |
Generic Equivalents to Penlac(R) Nail Lacquer Topical Solution and Claritin(R) Syrup
HAWTHORNE, NY, USA | September 20, 2007 | Taro Pharmaceutical Industries Ltd. ("Taro," Pink Sheets: TAROF) reported today that it has received approvals 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") and its Supplemental ANDA for Loratadine Syrup (Oral Suspension), 5 mg/5 mL ("loratadine syrup") in a grape flavored formulation, an over-the-counter (OTC) product.
Ciclopirox nail lacquer is a prescription pharmaceutical product used for the topical treatment of onychomycosis, a fungal infection of the fingernails and toenails. 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 US LLC. According to industry sources, Penlac(R) Nail Lacquer has annual U.S. sales of approximately $88 million.
Taro's loratadine syrup is bioequivalent to Schering's Claritin(R) syrup. Loratadine syrup is an over-the-counter medication used for the relief of symptoms due to seasonal allergic rhinitis. Taro believes that this formulation is the first grape flavored loratadine syrup product in the U.S. market. According to industry sources, loratadine syrup products have annual U.S. sales of approximately $25 million.
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 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 of 1995, including statements regarding Taro's ciclopirox nail lacquer and loratadine syrup products. Although Taro 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 ciclopirox nail lacquer and loratadine syrup products and other products; changes in Taro's financial position; regulatory actions; and, other risks detailed from time to time in the Taro's SEC reports, including its Annual Repots on Form 20-F. Forward-looking statements speak only as of the date on which they are made. Taro 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 Industries Ltd.
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