04.09.2014 13:09:26
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Aradigm Says FDA Grants Fast Track Status To Pulmaquin
(RTTNews) - Aradigm Corp. (ARDM) Thursday said the U.S. Food and Drug Administration has granted Fast Track designation to its lead product candidate, Pulmaquin, for treatment of non-cystic fibrosis bronchiectasis or non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa.
Aradigm is currently in Phase 3 clinical trials for this indication. The Fast Track designation for Pulmaquin follows the Qualified Infectious Disease Product designation that was granted earlier this year.
The FDA gives Fast Track status to facilitate the development of new drugs intended to treat serious or life-threatening conditions and which demonstrate the potential to address unmet medical needs. The goal is to get important new drugs to patients earlier.
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