Taro Pharmaceutical Industries (Taro) has received approval from FDA for its Abbreviated New Drug Application (ANDA) for cetirizine hydrochloride tablets (OTC), 5mg and 10mg (Cetirizine Tablets). The product will be marketed by Taro’s US affiliate, Taro Pharmaceuticals USA.
The company said that Cetirizine tablets are bioequivalent to McNeil consumer healthcare’s Zyrtec Allergy Tablets, 5mg and 10mg, and Zyrtec Hives Relief Tablets, 5mg and 10mg.
Reportedly, Cetirizine Tablets are a nonprescription drug approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing, runny nose, itchy, watery eyes, itchy throat or nose) in adults and children two years of age and older. The tablets are also approved for the relief of itching due to hives in adults and children six years of age and older.
Taro is a science-based pharmaceutical company, engaged in meeting the needs of its customers through the discovery, development, manufacturing and marketing of the healthcare products.