New OTC Nasal Spray for Allergy Relief Granted FDA Approval

Officials with the FDA have approved azelastine hydrochloride 0.15% (Astepro Allergy; Bayer) as an OTC product for the temporary relief of nasal congestion, runny nose, sneezing, and itchy nose associated with upper respiratory allergies such as hay fever. According to Bayer, the approval is the FDA’s first for a steroid-free, antihistamine nasal spray for allergies available OTC in the United States.

More than 50 million Americans are affected by allergies each year, according to Bayer. Azelastine hydrochloride 0.15% is indicated for adults and children 6 years of age and older.

According to Catherine Vennat, vice president and general manager, GM Bayer Consumer Health US, azelastine HCI 0.15% addresses an unmet need for patients with allergic rhinitis. The approved OTC formulation is full prescription strength and can provide relief from allergy nasal symptoms that will last up to 24 hours.

Azelastine is currently only available with a prescription in the United States. According to Bayer, azelastine hydrochloride 0.15% is expected to become available in retail locations in early 2022.

Currently, OTC allergy medications includes 3 major classes: antihistamines, intranasal steroids, and mast cell stabilizers. Azelastine hydrochloride 0.15% will be the only OTC antihistamine nasal spray for indoor and outdoor allergy relief.

REFERENCE

FDA Approves Astepro Allergy Nasal Spray for Over-the-Counter Use in the United States [news release]. June 17, 2021; Bayer. Accessed June 17, 2021. https://www.businesswire.com/news/home/20210617005872/en/FDA-Approves-Astepro%C2%AE-Allergy-Nasal-Spray-for-Over-the-Counter-Use-in-the-United-States