FDA Approves Bayer's Nonprescription, Nasal Antihistamine

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The U.S. Food and Drug Administration has approved Bayer AG's (BAYZF.PK) Astepro, a nasal spray to relieve allergy symptoms, to be sold without prescription.

Under a process called partial prescription to nonprescription switch, the FDA approved nasal antihistamine for nonprescription use through. Astepro can be used for seasonal and perennial 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 approval makes Astepro the first antihistamine nasal spray for allergies available over the counter in the U.S., the FDA noted.

Astepro, or azelastine hydrochloride nasal spray, offers patients once- or twice-daily dosing and provides up to 24 hours relief of allergic symptoms such as nasal congestion, running nose and sneezing, the company said.

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.

Meanwhile, Bayer said it will make the drug available at national retail locations in the first quarter next year.

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