Taro Receives FDA Approval Of New Drug Application For Flo-Pred(TM) (Prednisolone Acetate Oral Suspension)

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Allergy
Article Date: 25 Jan 2008 - 1:00 PDT

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Taro Pharmaceutical Industries Ltd. (the "Company" or "Taro," Pink Sheets: TAROF) reported 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.

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.

For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at http://www.taro.com.

Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Taro's new Flo-PredTM product. These statements include, but are not limited to, statements that do not describe historical facts and statements that refer or relate to events or circumstances the Company "plans," "believes," or "expects" to happen, "may" happen, or similar language. Although Taro believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; marketplace acceptance of the new Taro product or its other products; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.

Taro Pharmaceutical Industries Ltd.