Taro Pharmaceutical Industries Ltd. said its US affiliate, Taro Pharmaceuticals USA., Inc. has received approval from the US Food and Drug Administration for its New Drug Application (NDA) for Flo-Pred (prednisolone acetate oral suspension) equivalent to 5 mg/5 mL and 15 mg/5 mL prednisolone in Taro's patent-protected NonSpil liquid drug delivery system.

Flo-Pred 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-Pred does not require refrigeration and does not require shaking prior to use. The patent-protected taste masking formula has a cherry flavour which may be helpful in administering the product to children, said the company in a recent press statement.

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.

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.