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Pharmaxis Faces New Study Requirement For CF Drug Bronchitol

 
• By Sue Sutter

In a “complete response” letter, FDA says efficacy has not been adequately demonstrated for use of dry powder mannitol in cystic fibrosis patients ages six years and older.

Pharmaxis Ltd. faces the prospect of having to conduct a new clinical trial of Bronchitol (mannitol inhalation powder) in adult and pediatric cystic fibrosis patients now that FDA has issued a “complete response” letter citing inadequate evidence of efficacy.

On March 19, the Australian specialty pharmaceutical company announced that FDA declined to approve its NDA for dry powder mannitol to improve pulmonary function in CF patients ages six years and older, and that

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