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.
- MHRA Approves Nuromol (Combined Paracetamol and Ibuprofen) for General Sale in UK
- FDA Approves “First-in-Class” Nasal Antihistamine (Astepro Allergy) For OTC
- Clark Richardson Participates in June 2021 FDA Public Workshop on the OTC Drug Facts Label
- PEGUS Announces Even More Enhancements to Its “Decentralized” Research Model
- Brandon Henrie Promoted to Vice President – Finance and Strategy