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Pharmaxis Bid For U.S. CF Drug Approval Rejected For Lack Of Risk Data

This article was originally published in PharmAsia News

Executive Summary

Pharmaxis has been rejected in its bid for U.S. FDA approval of its Bronchitol (mannitol) cystic fibrosis inhalant drug, but the Aussie drug maker could submit additional data that would change the agency's mind.

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