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Bronchitol (Pharmaxis) is rejected by FDA Advisory Committee as a treatment for Cystic Fibrosis

Read time: 1 mins
Last updated: 2nd Feb 2013
Published: 2nd Feb 2013
Source: Pharmawand

Pharmaxis has received a negative recommendation from the Pulmonary-Allergy Drugs Advisory Committee (PADAC) advising the FDA on the use of Bronchitol (inhaled dry powder mannitol) for Cystic Fibrosis patients in the United States.

The PADAC voted on three questions relating to Bronchitol�s safety and efficacy in Cystic Fibrosis patients aged 6 years and over, with a negative result on all questions. The drug, which is intended to clear mucus in the lungs of Cystic Fibrosis patients, is available to patients aged 6 years and older in Australia to patients 18 years and older in the European Union.

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