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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.

Development timeline for Astepro Allergy

DateArticle
Jun 17, 2021Approval FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use
Sep  2, 2009Approval Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine
Oct 17, 2008Approval 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.