Taro Pharmaceutical Industries Ltd. has received approvals from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Ciclopirox topical solution, 8 per cent (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.
According to a company press release, 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 nail lacquer (ciclopirox) topical solution, 8 per cent, of Sanofi-Aventis US LLC. According to industry sources, penlac nail lacquer has annual US sales of approximately $88 million.
Taro's loratadine syrup is bio equivalent to Schering's claritin 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 flavoured loratadine syrup product in the U.S. market. According to industry sources, loratadine syrup products have annual US sales of approximately $25 million, the company said.
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.