FDA Approves a Nasal Antihistamine for Nonprescription Use

The FDA granted the approval of nonprescription Astepro to Bayer Healthcare LLC.

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.

Masters of Pediatrics™ (MoP) is dedicated to the advancement of healthcare technologies and education serving as the academic home for child health professionals. Masters of Pediatrics offers continuing medical education, activities, and training through its advanced education entity Metabolic Medical Institute (MMI).
A division of Tarsus Medical owned by Tarsus Group
About

+1 (888) 555-1212

Copyright © 2021, A4M. All trademarks, registered or unregistered, are the property of their respective owners.