The Food and Drug Administration (FDA) has approved a prescription to over-the-counter (OTC) switch for Astepro® Allergy (azelastine hydrochloride nasal spray, 0.15%), an antihistamine, 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 of age and older. 

The OTC formulation of Astepro is a first-in-class switch for an antihistamine nasal spray and will be available in full prescription strength. Each nasal spray delivers 0.137mL solution containing 205.5mcg of azelastine hydrochloride. The product may be administered as a once daily or twice daily dosing regimen. 

Due to the risk of somnolence associated with the use of azelastine, the label for Astepro Allergy warns consumers to avoid alcoholic drinks and to be cautious when driving a motor vehicle or operating machinery. Additionally, consumers should avoidsedatives, or tranquilizers when using the product.

While the 0.15% strength is approved for OTC use, the 0.1% strength for Astepro will remain prescription based for seasonal and perennial allergic rhinitis. The Company expects to have Astepro Allergy available at national mass retail locations in the first quarter of 2022.


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“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 M. Michele, MD, 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.”

Reference

  1. FDA approves a nasal antihistamine for nonprescription use. [press release]. Silver Springs, MD: US Food and Drug Administration; June 17, 2021. 
  2. FDA approves Astepro® Allergy nasal spray for over-the-counter use in the United States. [press release]. Whippany, NJ: Bayer; June 17, 2021.