Cayston FDA Approval History
FDA Approved: Yes (First approved February 22, 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 timeline for Cayston
|Feb 23, 2010||Approval 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, 2009||FDA Advisory Committee Supports Use of Aztreonam for Inhalation Solution for Patients With Cystic Fibrosis|
|Oct 26, 2009||Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009|
|Feb 19, 2009||Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution|
|Sep 17, 2008||Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis|
|Nov 26, 2007||PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation|
|Nov 16, 2007||Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis|
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