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Bronchitol Approval Status

FDA Approved: No
Brand name: Bronchitol
Generic name: mannitol
Company: Pharmaxis
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of mannitol in development to improve lung function in patients with cystic fibrosis.

Development Status and FDA Approval Process for Bronchitol

DateArticle
Dec 20, 2018Pharmaxis Announces Resubmission of Bronchitol NDA
Oct 25, 2010Pharmaxis Announces Positive Combined Phase 3 Cystic Fibrosis Trial Results
Jun 24, 2010Pharmaxis Announces Results For Second Phase III Trial Of Bronchitol In Cystic Fibrosis
May 19, 2010Pharmaxis Announces Sustained Benefit In Cystic Fibrosis Following Long Term Bronchitol Treatment
Dec  4, 2009Pharmaxis Announces Sustained Benefit With Bronchitol In Phase 3 Cystic Fibrosis Trial
Aug 20, 200812 Month Phase 3 Trial Finds Bronchitol Safe in Bronchiectasis
Aug 12, 2008Bronchitol Cystic Fibrosis Dose Trial Results Positive
Jun 12, 2008Pharmaxis Long-Term Safety Study of Bronchitol Completes
Aug 29, 2007Phase III Trial Finds Pharmaxis' Bronchitol Effective

Further information

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