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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: aztreonam
Date Designated: 05/15/2009
Orphan Designation: Improvement of respiratory symptoms in patients with bronchiectasis and gram-negative bacteria in the airways.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/12/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Gilead Sciences, Inc.
2025 1st Avenue
Seattle, Washington 98121
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.