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news.Pharmaceutical company Taro has received FDA approval for its abbreviated new drug application for ciclopirox topical solution, and supplemental abbreviated new drug application for loratadine syrup, an over-the-counter product.
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Ciclopirox nail lacquer is a prescription pharmaceutical product used for the topical treatment of onychomycosis. Taro says the FDA has determined that its ciclopirox nail lacquer is safe and effective for use when compared with the reference-listed drug product, Penlac Nail Lacquer, topical solution 8%, of Sanofi-Aventis.
The first grape flavored loratadine syrup is bioequivalent to Schering’s Claritin syrup and is used for the relief of symptoms due to seasonal allergic rhinitis. Taro believes that this formulation has an annual US sales of approximately $25 million.