Synthon receives FDA final approval for generic Xyzal

PerrigoNov 29 2010

Perrigo (Nasdaq: PRGO;TASE) today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal® tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis. Perrigo has the exclusive rights from Synthon to sell and distribute the product in the U.S. The Synthon product is the only approved generic product having a label containing all indications as the brand product and is entitled to 180 days of exclusivity for a product labeled for both allergy and hives. Product shipments commenced immediately upon FDA approval.

Levocetirizine tablets (Xyzal®) are indicated for the treatment of indoor and outdoor allergies. According to Wolters Kluwer Health, sales for Xyzal Tablets for the 12 month period ending September 2010, were $224 million, a 12% increase over the previous 12 month period.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This is a terrific example of Perrigo leveraging its strong partnerships in bringing new products to market. We are excited to see the continued expansion of our generic Rx portfolio of products."

Synthon's CEO Rudy Mareel commented, "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."