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Cayston Approval History

  • FDA approved: Yes (First approved February 22nd, 2010)
  • Brand name: Cayston
  • Generic name: aztreonam lysine
  • Dosage form: Inhalation Solution
  • Company: Gilead Sciences, Inc.
  • Treatment for: Pneumonia with Cystic Fibrosis

Cayston (aztreonam lysine for inhalation) is an inhaled anti-pseudomonal therapy for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa infection.

Development History and FDA Approval Process for Cayston

DateArticle
Feb 23, 2010Approval U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
Dec 11, 2009FDA Advisory Committee Supports Use of Aztreonam for Inhalation Solution for Patients With Cystic Fibrosis
Oct 26, 2009Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009
Feb 19, 2009Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution
Sep 17, 2008Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
Nov 26, 2007PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation
Nov 16, 2007Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis

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