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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  encochleated amikacin
Date Designated:  03/03/2016
Orphan Designation:  Treatment of non-tuberculous mycobacteria (NTM) infections
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Matinas BioPharma Nanotechnologies, Inc
1545 Route 206 South, Suite 302
Bedminster Township, New Jersey 07921
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.