FDA Approves a Nasal Antihistamine for Nonprescription Use

Approval is a First-in-class and was Enabled by the Prescription to Nonprescription Switch Process

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Jun 17, 2021, 18:04 ET

SILVER SPRING, Md., June 17, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration today 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.

"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, M.D., 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."

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.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration