• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
Generic Name: aztreonam
Trade Name: Cayston
Date Designated: 03/12/2002
Orphan Designation: Inhalation therapy for control of gram-negative bacteria in the respiratory tract of patients with cystic fibrosis
Orphan Designation Status: Designated/Approved
Gilead Sciences, Inc.
199 East Blaine St
Seattle, Washington 98102
United States

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

Marketing approved:

1 Generic Name: aztreonam
Trade Name: Cayston
Marketing Approval Date: 02/22/2010
Approved Labeled Indication: To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa
Exclusivity End Date: 02/22/2017 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.