FDA Approves Nasal Antihistamine spray for seasonal and perennial allergic rhinitis
The U.S. Food and Drug Administration has granted approval to 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.The nasal antihistamine has been approved for nonprescription use through a process called a partial prescription to nonprescription switch.
The FDA has granted the approval of nonprescription Astepro to Bayer Healthcare LLC.
"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."
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