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Breztri Aerosphere FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved July 23, 2020)
Brand name: Breztri Aerosphere
Generic name: budesonide/glycopyrrolate/formoterol fumarate
Dosage form: Metered Dose Inhalation
Company: AstraZeneca
Treatment for: COPD

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a fixed dose triple-combination of the inhaled corticosteroid budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta2-agonist (LABA) formoterol fumarate, delivered in a pressurized metered-dose inhaler for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

  • Breztri Aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
  • Breztri Aerosphere is administered by oral inhalation twice daily (2 puffs in the morning and 2 puffs in the evening). Patients should always rinse their mouth with water after each dose to reduce the risk of Candida albicans infection (oral thrush).
  • Breztri Aerosphere is not meant to relieve acute symptoms of COPD. Patients should always have available a rescue inhaler (an inhaled, short-acting bronchodilator) to treat sudden breathing problems.
  • Common adverse reactions include upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, urinary tract infection, cough, sinusitis and diarrhea.

Development timeline for Breztri Aerosphere

Jul 24, 2020Approval FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the Maintenance Treatment of COPD
Oct  1, 2019AstraZeneca Announces FDA Complete Response Letter Regarding NDA for PT010 in COPD
Jan 26, 2018AstraZeneca Reports Top-Line Phase III KRONOS Trial Results for PT010 Triple Combination Therapy in Chronic Obstructive Pulmonary Disease

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.