Astepro Allergy FDA Approval History
Last updated by Judith Stewart, BPharm on June 28, 2021.
FDA Approved: Yes (First approved June 17, 2021)
Brand name: Astepro Allergy
Generic name: azelastine
Dosage form: Nasal Spray
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Allergic Rhinitis
Astepro Allergy (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.
- Astepro Allergy is an over-the-counter formulation of prescription strength Astepro.
- Astepro Allergy is used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older.
- For adults and children 12 years and older:
- Astepro Allergy can be used once daily (2 sprays in each nostril) or twice daily (1 or 2 sprays in each nostril every 12 hours).
- Do not use more than 4 sprays in each nostril in a 24 hour period.
- For children 6 years to 11 years (use under adult supervision):
- Astepro Allergy can be used twice daily (1 spray in each nostril every 12 hours).
- Do not use more than 2 sprays in each nostril in a 24 hour period.
- For adults and children 12 years and older:
Development timeline for Astepro Allergy
| Date | Article |
|---|---|
| Jun 17, 2021 | Approval FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use |
| Sep 2, 2009 | Approval Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine |
| Oct 17, 2008 | Approval FDA Approves Astepro for the Treatment of Seasonal Allergic Rhinitis |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.