Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF.PK) reported today that it has received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for a generic version of Zyrtec allergy medication.
The drug approved is cetirizine hydrochloride oral solution (1 mg / 1 mL), which Taro terms Cetirizine Oral Solution. It is bioequivalent to McNeil Consumer Healthcare’s Zyrtec Oral Solution. Cetirizine Oral Solution is an over-the-counter antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies and for the relief of itching due to hives.
According to industry sources, annual US sales of this product, when it was previously sold by prescription only, were approximately $160 million.
About a week ago, another Israeli pharmaceutical firm, Perrigo Company (Nasdaq:PRGO; TASE:PRGO), won FDA approval for a children's version of cetrizine. Perrigo was not granted exclusivity.
Yakum-based Taro ended yesterday at $8.25 in over-the-counter trade.
Published by Globes [online], Israel business news - www.globes-online.com - on April 23, 2008
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