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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  liposomal amikacin
Trade Name:  Arikayce
Date Designated:  03/25/2013
Orphan Designation:  Treatment of infections caused by non-tuberculous mycobacteria
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/28/2018 
Approved Labeled Indication:  Treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy
Exclusivity End Date:    09/28/2025 
Exclusivity Protected Indication* :  Treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy
Insmed Incorporated
10 Finderne Avenue
Building 10
Bridgewater, New Jersey 08807
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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