Allegan-based Perrigo Co. (Nasdaq: PRGO) and its partner Synthon Pharmaceuticals Inc. said Wednesday that they had received tentative approval from the U.S. Food and Drug Administration for an 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 growing at 15 percent per year, according to data provided by Wolters, Kluwer.
Said Perrigo chairman and CEO Joseph C. Papa: “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.”
Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products and active pharmaceutical ingredients. The company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. Perrigo’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.