Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride oral solution, 1 mg / 1 mL ("Cetirizine Oral Solution").
The product will be marketed by Taro’s U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.
Taro’s Cetirizine Oral Solution 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 U.S. sales of this product, when it was previously sold by prescription only, were approximately $160 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.