Taro gains final FDA appro for cetirizine

29 June 2008

Israel-headquartered Taro Pharmaceutical Industries, which recently pulled out of a merger deal with India's Sun Pharmaceuticals (Marketletter June 9), says that it has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for prescription cetirizine HCl syrup, 1mg/1mL. Taro had received tentative approval for this ANDA in October 2007.

Taro's cetirizine syrup is bioequivalent to McNeil Consumer Healthcare's Zyrtec Syrup, a prescription medicine used for the relief of symptoms associated with perennial allergic rhinitis in children six to 23 months of age, and for chronic urticaria (hives) in those of six months to five years. According to industry sources, annual US sales of cetirizine syrup products were approximately $150.0 million.

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