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Bronchitol Gets Narrow Approval Vote From Advisory Cmte., Leaving US FDA Host Of Issues To Consider

 
• By Michael Cipriano

Pulmonary-Allergy Drugs Advisory Committee votes 9-7 that the benefits of Pharmaxis' cystic fibrosis drug outweigh its risks, leaving the FDA with a muddled verdict.  

FDA Advisory Committee Feature image

The US Food and Drug Administration will have a host of issues to balance as it completes the review of Pharmaxis Ltd.'s cystic fibrosis drug Bronchitol (mannitol inhalation powder) after the Pulmonary-Allergy Drugs Advisory Committee narrowly voted that the risk/benefit profile is adequate to support approval by a 9-7 margin.

At the 8 May meeting, panelists offered a muddled verdict to the agency with a variety of arguments focusing on the drug's safety, efficacy and use in clinical practice.

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