FDA Approves Nasal Spray Astepro for Nonprescription Use

The FDA has approved Bayer’s nasal spray Astepro (azelastine hydrochloride) for nonprescription use for seasonal and perennial allergies.

The approval for use by adults and children six years and older was granted based on data that showed the drug to be safe and effective for self-medication based on the instructions for use on the proposed product labeling.

Astepro first received FDA approval as a prescription-only nasal antihistamine in October 2008.