The FDA announced that it has approved Astepro azelastine hydrochloride nasal spray, 0.15%, for nonprescription use by adults and children aged 6 and older for the treatment of seasonal and perennial allergic rhinitis. Astepro Allergy will be the only antihistamine nasal spray for allergies available OTC in the US. The 0.1% strength, which includes pediatric indications, will remain as a prescription drug.
Astepro was developed by Meda and was originally approved in the US in 2008. Meda was acquired by Mylan in 2016 and Mylan is now part of Viatris. The approval for Astepro Allergy was granted to Bayer Healthcare, which said that Astepro Allergy is expected to be available in US retail stores in the first quarter of 2022.
FDA Director of the Office of Nonprescription Drugs Theresa M. Michele commented, “Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more. Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.”
Bayer Consumer Health US VP and General Manager Catherine Vennat said, “At Bayer, we help make self-care a reality for billions through everyday healthcare. This new differentiated product is one step in that direction, with the potential to help millions of people in the US that suffer from seasonal allergic rhinitis. 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 a crucial differentiated allergy product to the Bayer allergy portfolio to address unmet consumer needs with allergic rhinitis.”
Read the FDA press release.
Read the Bayer press release.
