US – The US Food and Drug Administration (FDA) has approved Bayer’s steroid-free antihistamine nasal spray Astepro for over-the-counter use.
Astepro becomes the first and only OTC steroid-free antihistamine nasal spray available in the US for adults and children aged six years and older.
Currently, OTC allergy medications is classified into three major classes which include antihistamines, intranasal steroids and mast cell stabilizers.
Bayer, a German multinational pharmaceutical and life sciences company had astepro previously approved for prescription use in 2008.
Following the approval by the FDA, Astepro will be available in the US as an OTC product for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies.
OTC drugs are medications that are safe and effective for use by the general public without seeking treatment from a healthcare professional.
Many OTC drugs have undergone a prescription to over-the-counter switch, also known as “Rx-to-OTC switch”, meaning they were previously available only with a prescription but now can be bought as a nonprescription product and a good example is Astepro.
The review of OTC medications is primarily handled by the U.S.(FDA’s) Division of Drug Information, the Office of Drug Evaluation, and the Nonprescription Drug Advisory Committee.
These teams evaluate and review OTC ingredients and labels as an OTC drug monograph is established for each class of product and usually the monograph contains acceptable ingredients, doses, formulations, and labeling.
With the growing market of OTC that was once overshadowed by the prescription medication market, users have been able to enjoy a couple of benefits from the OTC market.
The OTC medication has increased accessibility to drugs for chronic common diseases like diabetes, it has been helpful when it comes to patient autonomy and has also provided low cost treatment options.
Even though the approval has been confirmed, Astepro will not be immediately available to patients until the first quarter of 2022 according to Bayer.