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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Tobramycin
Date Designated: 06/18/1999
Orphan Designation: Treatment of bronchiectasis patients infected with Pseudomonas aeruginosa.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaceuticals Corp.
One Health Plaza
Office 315
East Hanover, New Jersey 07936
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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