Perrigo Company and its partner Synthon Pharmaceuticals, Inc. announced that it has received tentative approval from the US Food and Drug Administration for its abbreviated new drug application for Levocetirizine Solution, 2.5 mg/5ml, a generic version of UCB’s Xyzal Oral Solution. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.

Xyzal Oral Solution is indicated for the treatment of indoor and outdoor allergies. It is estimated that it has annual sales of approximately $15 million dollars growing at 15% per year, according to data provided by Wolters, Kluwer.

Perrigo’s chairman and CEO Joseph C Papa concluded, “This is another example of Perrigo’s commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers.”

Synthon’s CEO Rudy Mareel, commented, “Levocetirizine is a prime example of several ANDAs for which Synthon has obtained ‘First-Filer’-status with 180 days Hatch-Waxman marketing exclusivity. The tentative approval of Levocetirizine oral solution yet again is proof to Synthon’s achievements and our fruitful 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 and active pharmaceutical ingredients (API).

Synthon Pharmaceuticals, Inc., markets generic drugs through partnerships with other leading pharmaceutical companies and currently holds several approved, or tentatively approved, drug applications and has a pipeline containing more than a dozen products that are expected to be filed with the FDA within the next few years.