US Pharm. 2011;36(1):60.
Perrigo announced that its licensor and supplier Synthon has received final approval from the FDA for levocetirizine tablets, a generic version of Xyzal Tablets (UCB/Sepracor), which is marketed in the United States by Sanofi-Aventis. Perrigo has exclusive rights from Synthon to sell and distribute the product in the U.S. The Synthon product is entitled to 180 days of exclusivity for a product labeled for both allergy and hives and is the only approved generic product having a label containing all the same indications as the brand product. Levocetirizine tablets are indicated for the treatment of indoor and outdoor allergies. Sales for Xyzal Tablets for the 12-month period ending September 2010 were $224 million, a 12% increase over the previous 12-month period, according to Wolters Kluwer Health.
Synthon's CEO, Rudy Mareel, said, “Levocetirizine is one of several ANDAs for which Synthon has obtained 'First-Filer'-status with 180 days Hatch-Waxman marketing exclusivity. We are proud of this achievement and of our cooperation with Perrigo.”
