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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Levofloxacin
Date Designated: 02/27/2008
Orphan Designation: Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis patients
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Horizon Therapeutics USA, Inc.
150 S. Saunders Road
Suite 100
Lake Forest, Illinois 60045
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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