FDA approves nasal antihistamine for non-prescription use

The United States Food and Drug Administration (FDA) has approved Azelastine Hydrochloride 0.15% Nasal Antihistamine Nasal Spray (Astepro) for non-prescription use in people 6 years of age and older.

The indication, granted to Bayer Healthcare, allows patients who have received a “partial prescription” to switch to non-prescription use of nasal allergy spray for the treatment of seasonal and perennial allergic rhinitis.

The new decision is based on data proving the safety and efficacy of azelastine hydrochloride as a self-medication, as stated in the proposed labeling for the therapy. In order to ensure the benefits and safety without a prescription, manufacturers also had to show the consumer’s ability to use without the supervision of a healthcare provider.

According to the FDA, the approval is a first-rate change for a nasal antihistamine, but due to its 0.1%, it is considered a partial change. Thus, the indication of perennial allergy for children from 6 months to 6 years old and the indication of seasonal allergy for children from 2 to 6 years old remain prescribed.

Azelastine hydrochloride includes a label warning that users should avoid alcoholic beverages and use caution while operating a motor vehicle or machinery, due to the drowsiness associated with the drug.

In a declaration Accompanying the indication for change, Theresa M. Michele, MD, director of the over-the-counter drugs office at the FDA’s Center for Drug Evaluation and Research, stressed the importance of the increased availability of the antihistamine nasal spray.

“Seasonal and perennial allergies affect millions of Americans each year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more,” Michele said. “Today’s approval provides individuals with an option for a safe and effective nasal antihistamine without the need for the assistance of a health care provider.”