FDA Approves Nasal Antihistamine for Nonprescription Use
The US Food and Drug Administration has approved astepro (azelastine hydrochloride nasal spray, 0.15%), a nasal antihistamine, for nonprescription use in the treatment of seasonal and perennial allergic rhinitis in individuals aged 6 years or older.
This is a first-in-class partial switch from prescription to nonprescription, considered “partial” because the 0.1% strength option with a perennial allergy indication for children aged 6 months to 6 years, and the seasonal allergy indication for children aged 2 to 6 years will remain prescription only.
The most common adverse effect of the antihistamine is drowsiness.
FDA approves a nasal antihistamine for nonprescription use. News release. US Food and Drug Administration. June 17, 2021. Accessed June 18, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-antihistamine-nonprescription-use