Perrigo files for approval of generic nasal allergy drug
ALLEGAN, Mich. — Perrigo is seeking approval from the Food and Drug Administration for a drug used to treat allergies in adolescents and adults, the company said Monday.
Perrigo announced that it filed a regulatory application with the FDA for azelastine hydrochloride nasal spray in the 0.15% strength. The drug is a generic version of Meda Pharmaceuticals' Astepro, used to treat nasal symptoms caused by seasonal allergies and environmental irritants in patients ages 12 years and older. Impax Labs has contributed to the filing as well, and both companies plan to share costs and benefits.
Meda filed suit against Perrigo last week in the U.S. District Court for the District of New Jersey in response to the filing, alleging patent infringement. The drug has sales of $114 million per year, according to Wolters Kluwer Health.