Perrigo Gets FDA Approval For Generic Version Of Astepro Nasal Spray

(RTTNews) - Perrigo Company plc (PRGO) announced Monday that it has received final approval from the U.S. Food and Drug Administration or 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. (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.