FDA Approves “First-in-Class” Nasal Antihistamine (Astepro Allergy) For OTC

On 17 June 2021, the US Food and Drug Administration (FDA) announced approval of a new nasal antihistamine (Astepro Allergy and Children’s Astepro Allergy) for nonprescription use.  FDA described this as a “first-in-class switch” of a nasal antihistamine for seasonal and perennial allergies.  It is a “partial switch” because the allergy indications for children under 6 years of age will remain prescription.  PEGUS was privileged to support label development and comprehension testing, and warmly congratulates the sponsor on this new OTC product approval success.