FDA approves Bayer’s Astepro for OTC use in US

FDA approves Bayer’s Astepro for OTC use in US

The U.S. Food and Drug Administration (FDA) has approved Bayer’s nasal antihistamine for non-prescription use through the process of partial prescription to non-prescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older.

The approval is a first-in-class switch for a nasal antihistamine and is considered a partial switch because the 0.1% strength, which includes the perennial allergy indication for children 6 months to 6 years old and seasonal allergy indication for children 2 to 6 years old, will remain prescription based.

Theresa M. Michele, M.D., director of the office of non-prescription drugs in the FDA’s Center for Drug Evaluation and Research said: “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.”

In a statement from Bayer, Catherine Vennat, VP/GM Bayer Consumer Health U.S 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 U.S. 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.”