The FDA removed the prescription requirement for Bayer’s Asteprofor seasonal and year-round allergic rhinitis nasal spray.
It is considered a “partial switch,” because the drug’s use in children younger than six still requires a prescription.
The approval makes Astepro the first antihistamine nasal spray for allergies available over the counter in the U.S., the FDA noted. Antihistamines represent a major class of OTC allergy meds, but they’re given by mouth.
U.S. patients won’t be able to immediately get Astepro off the shelf, though; Bayer will make the drug available at national retail locations in the first quarter next year, the company said in a statement Thursday.
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.