FDA Approves Over-the-Counter Nasal Antihistamine

The U.S. FDA approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis(allergies) for adults and children six years of age and older. 

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

For a drug to move from prescription to nonprescription status, data must demonstrate the drug’s safety and effectiveness for use as label-directed self-medication. The manufacturer must show that consumers understand how to use the drug safely and effectively without the supervision of a healthcare professional. This 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.

Azelastine can cause drowsiness. The label warns that consumers using this product should avoid alcoholic drinks and be careful when driving a motor vehicle or operating machinery. Using azelastine nasal spray with alcohol, sedatives, or tranquilizers may increase drowsiness.

The FDA granted the approval of nonprescription Astepro to Bayer Healthcare LLC.