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Bronchitol FDA Approval History

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

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

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.

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

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