TARO WINS APPROVAL FOR GENERIC MOBIC, TENTATIVE APPROVAL FOR GENERIC ZYRTEC

Taro Pharmaceutical Industries has received approval from the FDA for its abbreviated new drug application (ANDA) for meloxicam tablets, 7.5 and 15 mg.

Meloxicam is for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. The product is bioequivalent to Boehringer Ingelheim's Mobic. According to Taro, branded and generic meloxicam tablet products had U.S. sales of approximately $105 million in the third quarter of 2006.

Taro has also received tentative approval from the FDA for its ANDA for cetirizine hydrochloride syrup, 1 mg/mL. The FDA has determined that Taro's cetirizine syrup is safe and effective for use when compared with the reference listed drug product, Pfizer's Zyrtec Syrup. Zyrtec Syrup is a prescription product used for treating allergic rhinitis and chronic urticaria (hives). According to Taro, annual U.S. sales of Zyrtec Syrup are approximately $153 million.

The tentative approval represents the FDA's determination that Taro's ANDA submission satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions.