FDA OKs Bayer’s Astepro for OTC use

The Food and Drug Administration has approved Bayer's Astepro Allergy (Azelastine HCI 0.15%) as an over-the-counter product for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies.

With the FDA’s approval, Astepro Allergy becomes the first and only steroid-free antihistamine nasal spray for allergies available OTC for adults and children age 6 years old and older, the company said. 

“At Bayer, we help make self-care a reality for billions through everyday health care. This new differentiated product is one step in that direction, with the potential to help millions of people in the U.S. that suffer from seasonal allergic rhinitis,” said Catherine Vennat, vice president/general manager of Bayer Consumer Health U.S. “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.”

Astepro is currently only available with a prescription, and with this approval it will be the first and only OTC antihistamine nasal spray for indoor and outdoor allergy relief upon the OTC switch, the company said. 

“Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more,” said Theresa Michele, director of the office of nonprescription drugs in the FDA's Center for Drug Evaluation and Research. “Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.”

This OTC formulation is full prescription strength. The company noted that the drug's benefits include flexible once or twice daily dosing that provides up to 24-hour relief of nasal congestion, running nose, sneezing and itchy nose from indoor and outdoor allergies.

Astepro Allergy will be available at national mass retail locations in the first quarter of 2022.