ARTICLE | Clinical News

Bronchitol mannitol regulatory update

July 11, 2011 7:00 AM UTC

Pharmaxis requested re-examination of last month's negative opinion from EMA's CHMP for Bronchitol mannitol to treat cystic fibrosis (CF). The formulation of mannitol in a dry powder inhaler system is approved in Australia. The product has Orphan Drug designation in the EU and the U.S. and has Fast Track designation in the U.S. ...