FDA Approves a Nasal Antihistamine for Nonprescription Use
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The U.S. Food and Drug Administration 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—commonly known as allergies—for adults and children six years of age and older.

For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can 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.

Source:
https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-antihistamine-nonprescription-use
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