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Taro Receives FDA Approvals for Ciclopirox and Formulation of Loratadine
The FDA approved Taro Pharmaceutical’s abbreviated new drug application (ANDA) for ciclopirox topical solution, 8 percent, for nail fungus infections and its supplemental ANDA Loratadine syrup, 5 mg/5 mL, an OTC product for the treatment of seasonal allergic rhinitis. Ciclopirox nail lacquer is a prescription product used for the topical treatment of onychomycosis, a fungal infection of the nails. The FDA determined the product to be safe and effective when compared with sanofi-aventis’ Penlac nail lacquer (ciclopirox) topical solution, 8 percent. Taro’s loratadine syrup is bioequivalent to Schering’s Claritin syrup. Taro believes that this formulation is the first grape-flavored loratadine syrup product in the U.S. market. |
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