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# FDA OKs Expanded Labeling for Asthma Drug
- URL: https://www.fdaweb.com/fda-oks-expanded-labeling-for-asthma-drug/
- Published: 2025-09-18T12:00:00.000Z
- Updated: 2026-09-14T15:22:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159899

FDA has approved an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drug’s labeling to reflect a 46% reduction of severe exacerbation risk in patients with mild asthma compared with albuterol.

This finding came from the BATURA Phase 3b trial, which examined the efficacy of as-needed Airsupra compared to as-needed albuterol, the most commonly used rescue medication for asthma in the U.S., the company says.