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For Pseudomonas aeruginosa. NDA 50814, held by Gilead. Aztreonam.
As of Nov 13, 2026, NDA 50814 (Cayston), held by Gilead, was first approved by FDA on Feb 22, 2010, with 11 approved supplements and 0 published complete response letters.
First approved: Feb 22, 2010
Review: Standard
Supplements approved: 11
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV 1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
