Month Year
| Su | Mo | Tu | We | Th | Fr | Sa |
|---|---|---|---|---|---|---|
Month Year
| Su | Mo | Tu | We | Th | Fr | Sa |
|---|---|---|---|---|---|---|
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Jun 7, 2018
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May 22, 2018Data support the benefit of treating patients with a combination of ALIS (Amikacin Liposome Inhalation Suspension) and guideline-based therapy (GBT) for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)
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May 17, 2018
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May 16, 2018PDUFA Action Date Set for September 28, 2018
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May 2, 2018Submitted NDA to FDA for Amikacin Liposome Inhalation Suspension (ALIS) in NTM lung disease caused by MAC; anticipates priority review
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Mar 29, 2018ALIS previously designated as an orphan drug, breakthrough therapy and Qualified Infectious Disease Product (QIDP)
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Feb 23, 2018On track to file NDA before the end of March and anticipate a priority review
