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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
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.

Marketing approved:

1 Generic Name: liposomal amikacin
Trade Name: Arikayce
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
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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