Taro Pharmaceutical Industries has received final approval from the FDA for its abbreviated new drug application for prescription cetirizine hydrochloride syrup, 1mg/1ml.
Taro had received tentative approval for this abbreviated new drug application in October 2007. The company plans to market the product through its US affiliate, Taro Pharmaceuticals USA.
Taro’s Cetirizine syrup is bioequivalent to McNeil Consumer Healthcare’s Zyrtec syrup. Cetirizine syrup is a prescription medication used for the relief of symptoms associated with perennial allergic rhinitis in children six to 23 months of age, and for chronic urticaria in children six months to five years of age.
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