Nasal Allergy Rx to Go OTC

FDA approves Astepro nasal spray for nonprescription use

(RxWiki News) The US Food and Drug Administration (FDA) has approved a prescription allergy medication to be used without a prescription.

Astepro (azelastine hydrochloride nasal spray, 0.15%) has received the green light from the FDA to move from prescription to non-prescription status. That means this antihistamine nasal spray will be available over the counter (OTC).

The FDA approved Astepro to treat seasonal allergies in adults and children who are at least 6 years old.

“Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more,” said Dr. Theresa M. Michele, director of the FDA's Office of Nonprescription Drugs, in a press release. “Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.”

Astepro was already approved for prescription use. To make the leap to nonprescription approval, the drug has to be easy to use correctly without supervision of a health care provider. The manufacturer of the drug has to show the FDA that consumers can understand how to safely take the medication.

By approving Astepro for OTC use, the FDA is recognizing that the drug appears to be safe and easy to use without a health care provider's supervision.

This approval is considered a first-of-its-kind moment because, while it is now approved for OTC use in older children and adults, Astepro will still be available by prescription only for children younger than 6, the FDA noted.

This drug — whether prescription or OTC — can cause you to become drowsy. When using this medication, avoid consuming alcohol and take care when driving a vehicle. The FDA noted that taking Astepro with alcohol, tranquilizers or sedatives can increase drowsiness.

Always speak with your doctor or pharmacist before taking a new OTC medication or supplement. If you are dealing with seasonal or perennial allergies, talk to your health care provider about the best treatment for your unique case.

The FDA approved nonprescription Astepro for Bayer Healthcare LLC.

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Review Date: 
June 22, 2021