Search Orphan Drug Designations and Approvals
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Generic Name: | aztreonam | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | aztreonam |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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