Search Orphan Drug Designations and Approvals
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Generic Name: | liposomal amikacin |
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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Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 08/16/2023 |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 |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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