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.