Perrigo announced that its licensor and supplier Synthon has received final approval from the US Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal tablets from UCB/Sepracor, which is marketed in the US by sanofi-aventis. Perrigo has the exclusive rights from Synthon to sell and distribute the product in the US. 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 labelled 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.
Perrigos 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."
Rudy Mareel CEO Synthon 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."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products.
Synthon Pharmaceuticals, Inc., with its US headquarters and laboratories located in Research Triangle Park, North Carolina, markets generic drugs through partnerships with other leading pharmaceutical companies.