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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Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/16/2023
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 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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