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