US Pharm. 2012;36(2):40.
Perrigo Company announced that it has filed an ANDA with the FDA for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application, of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories, Inc., which will share costs and benefits of this project. 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 $114 million, according to Wolters Kluwer Health.On January 19, Meda Pharmaceuticals filed suit against Perrigo in the U.S. District Court for the District of New Jersey, alleging patent infringement.
