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."
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.
Astepro® is currently only available with a prescription in the U.S. Today's OTC approval of Astepro® Allergy will provide more than 50 million Americans that suffer from allergies each year over-the-counter access to this steroid free nasal spray optioni. Currently, OTC allergy medications includes three major classes: antihistamines, intranasal steroids and mast cell stabilizers. Astepro® Allergy will be the first and only OTC antihistamine nasal spray for indoor and outdoor allergy relief upon the OTC switch.
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.