DUBLIN, May 12, 2014 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO;TASE) announced that it has received final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%). The ANDA involved contributions from both Perrigo and Impax Laboratories, Inc. (Nasdaq: IPXL), who will share certain costs and benefits of this product. Perrigo and Impax continue to be in first to file Hatch Waxman patent litigation with Meda Pharmaceuticals Inc. in the United States District Court for the District of New Jersey. Perrigo has commenced shipment of product to its customers.
Astepro® Nasal Spray is a prescription medicine for people 12 years of age and older and is approved to treat nasal symptoms caused by seasonal allergies or environmental irritants. Annual sales were approximately $97 million annually, as measured by Symphony Health Solutions.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval is another example of our investment in new products and expansion of our extended topical product portfolio. We are pleased to be the partner of choice with Impax on this important product opportunity. As always, Perrigo is committed to making quality healthcare more affordable for our customers."
President of the Global Pharmaceuticals Division of Impax Dr. Carole Ben-Maimon stated, "We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base."About Perrigo Company plc From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri®. The Company is the world's largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo's mission is to offer uncompromised "Quality Affordable Healthcare Products™," and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as more than 40 other key markets worldwide, including Canada, China and Latin America. Visit Perrigo on the Internet ( http://www.perrigo.com). About Impax Laboratories, Inc.