Perrigo receives final approval from FDA for azelastine hydrochloride nasal spray ANDA
Published on May 12, 2014 at 11:27 AM
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."