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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 for inhalation
Trade Name: TOBI
Date Designated: 10/13/1994
Orphan Designation: Treatment of bronchopulmonary infections of Pseudomonas aeruginosa in cystic fibrosis patients.
Orphan Designation Status: Designated/Approved
Mylan Specialty LP
781 Chestnut Ridge Road
Regulatory Affairs-Greenbag Road
Morgantown, West Virginia 26505
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Tobramycin for inhalation
Trade Name: TOBI
Marketing Approval Date: 12/22/1997
Approved Labeled Indication: Management of cystic fibrosis patients with P.aeruginosa.
Exclusivity End Date: 12/22/2004 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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