Taro Pharmaceutical Industries Ltd. (the “Company” or “Taro,” Pink Sheets: TAROF) reported today that its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. (“Taro USA”) has received approval from the U.S. Food and Drug Administration for its New Drug Application (NDA) for Flo-PredTM (prednisolone acetate oral suspension) equivalent to 5 mg/5 mL and 15 mg/5 mL prednisolone in Taro’s patent-protected NonSpilTM liquid drug delivery system.
The Flo-PredTM brand, for which there are no generic equivalents, will be sold by prescription as an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications.
Taro’s Flo-PredTM does not require refrigeration and does not require shaking prior to use. The patent-protected taste masking formula has a cherry flavor which may be helpful in administering the product to children.
According to industry sources, the market for prednisolone oral liquid products was approximately $55 million in 2007. The Company plans to launch the product later this year and market it through its TaroPharma Division of Taro USA.
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