FDA OKs OTC Use of Steroid-Free Antihistamine Allergy Nasal Spray

The FDA has approved OTC azelastine HCl .15% (Astepro Allergy; Bayer).

Officials with the FDA have approved OTC azelastine HCl .15% (Astepro Allergy; Bayer) for the temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to hay fever or other upper respiratory allergies for adults and children 6 years and older.

The OTC formulation will be available in full prescription strength and includes flexible once or twice daily dosing that provides up to 24-hour symptom relief.

Prior to this approval, azelastine HCl .15% was only available with a prescription in the United States. With its OTC switch, azelastine HCl .15% is the only steroid-free, antihistamine nasal spray for allergies available over the counter.

“At Bayer, we help make self-care a reality for billions through everyday healthcare. This new differentiated product is 1 step in that direction, with the potential to help millions of people in the US that suffer from seasonal allergic rhinitis,” Catherine Vennat, VP/GM Bayer Consumer Health US, said in a statement. “With Astepro Allergy, allergy sufferers can get relief of allergy nasal symptoms in an over-the-counter treatment option without steroids or decongestants that will last up to 24-hours. It will bring crucial differentiated allergy product to the Bayer allergy portfolio to address unmet consumer needs with allergic rhinitis.”

OTC azelastine HCl .15% will be available at national mass retail locations in Q1 2022, according to Bayer.

Reference

  1. FDA Approves Astepro Allergy Nasal Spray for Over-the-Counter Use in the United States. News Release. Bayer; 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