Skip to main content

Bronchitol FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 19, 2021.

FDA Approved: Yes (First approved October 30, 2020)
Brand name: Bronchitol
Generic name: mannitol
Dosage form: Inhalation Powder
Company: Chiesi USA, Inc.
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of the sugar alcohol mannitol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

  • Because of the risk of bronchospasm, Bronchitol can only be used in adults who have passed the Bronchitol Tolerance Test (BTT).
  • Bronchitol is administered twice a day by oral inhalation, in the morning and evening, with the later dose taken 2-3 hours before bedtime.
  • Common adverse reactions, occurring in 3% or more of patients, include cough, hemoptysis, oropharyngeal pain, vomiting, bacteria sputum identified, pyrexia, and arthralgia.

Development Timeline for Bronchitol

DateArticle
Nov  2, 2020Approval  FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis
Dec 20, 2018Pharmaxis Announces Resubmission of Bronchitol NDA

Further information

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