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Taro receives FDA approval for Flo-Pred NDA

Taro Pharmaceutical Industries has reported that its US affiliate, Taro Pharmaceuticals USA, has received approval from the FDA for its new drug application for Flo-Pred equivalent to 5mg/5mL and 15mg/5mL prednisolone in Taro's patent-protected NonSpil liquid drug delivery system.

The company said that the Flo-Pred (prednisolone acetate oral suspension) 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.

The company plans to launch the product later in 2008 and market it through its TaroPharma Division of Taro USA.