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June 24, 2021Astepro Allergy Approved Under Partial Rx-to-OTC Switch
June 17, 2021 – The U.S. FDA has approved Astepro® Allergy (azelastine hydrochloride nasal spray, 0.15%), manufactured by Bayer, for over-the-counter (OTC) use to provide temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to hay fever or other upper respiratory allergies in individuals who are at least six years of age. Astepro Allergy is the first and only FDA-approved OTC antihistamine nasal spray for indoor and outdoor allergy relief.
The FDA approved Astepro Allergy is approved through a process known as partial prescription to nonprescription switch. Previously, the product was available only by prescription under the brand name Astepro®. When a drug switches from prescription to nonprescription status using this process, the manufacturer must demonstrate that consumers can safely and effectively use the drug according to OTC label instructions without being supervised by a healthcare professional. Astepro Allergy’s prescription to nonprescription switch is partial in nature because a 0.1% strength version of Astepro, which is used to treat allergies in children six months to six years of age, remains a prescription-only product.
Recommended dosing for the OTC Astepro Allergy in children 6-11 years old is one spray per nostril twice daily. For adults and children 12 years and up, recommended dosing is 1-2 sprays per nostril twice daily or two sprays per nostril once daily.
Bayer plans to launch Astepro Allergy in national retail locations during the first quarter of 2022.