Pharmaxis Faces New Study Requirement For CF Drug Bronchitol
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.
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.