Taro Pharmaceutical Industries Ltd. has received final approval from the US 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 US affiliate, Taro Pharmaceuticals USA, Inc.
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 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 US sales of cetirizine syrup products were approximately $150 million.
Taro 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.