June 23, 2008 - Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF, "Taro", the "Company") reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for prescription Cetirizine Hydrochloride Syrup, 1 mg / 1 mL ("cetirizine syrup"). Taro had received tentative approval for this ANDA in October 2007. The Company plans to market the product through its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.
Taro's cetirizine syrup is bioequivalent to McNeil Consumer Healthcare's Zyrtec(R) Syrup. Cetirizine syrup is a prescription medication used for the relief of symptoms associated with perennial allergic rhinitis in children 6 to 23 months of age, and for chronic urticaria (hives) in children 6 months to 5 years of age. According to industry sources, annual U.S. sales of cetirizine syrup products were approximately $150 million.
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