FDAsafety guidance72% confidence
FDA AP — BREZTRI AEROSPHERE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (copd) as AstraZeneca.
Regulatory Analysis
Application NDA212122. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRROLATE.
Supporting Context
- Therapeutic area
- Respiratory · COPD
- Sub-indication
- COPD
Related signal: AstraZeneca initiates Phase 3 extension study for Tozorakimab in COPD patients