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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
Date Designated:  03/09/2006
Orphan Designation:  Treatment of bronchopulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Insmed, Inc.
Princeton Corporate Plaza
9 Deer Park Drive, Suite C
Monmouth Junction, New Jersey 08852
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.