Pseudomonas Aeruginosa Infection

• FDA approval · 2021-07-13
  FDA Approved: TOBRAMYCIN — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for Tobramycin filed by Gland Pharma Limited.

• FDA approval · 2015-09-11
  FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for TOBI Podhaler (tobramycin) by Viatris Specialty LLC to update the product labeling.

• FDA approval · 2014-12-02
  FDA Approved: TOBRAMYCIN INHALATION SOLUTION PAK — Original Application (Genericus, Inc.)

  FDA approved Genericus, Inc.'s Tobramycin Inhalation Solution Pak, a generic version of tobramycin inhalation solution for patients with cys…

• FDA approval · 2014-07-09
  FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Cayston (aztreonam) submitted by Gilead Sciences, Inc.

• FDA approval · 2013-03-22
  FDA Approved: TOBI PODHALER — Original Application (Viatris Specialty LLC)

  FDA approved TOBI PODHALER (tobramycin inhalation powder) via an Original Application submitted by Viatris Specialty LLC.

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• CLINICAL_TRIALS approval · 2012-12-13
  Clinical Trial Update: Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

  Expanded access program update for aztreonam lysine inhalation (Cayston) in Canadian cystic fibrosis patients, noting marketing approval sta…

• FDA approval · 2010-02-22
  FDA Approved: CAYSTON — Original Application (Gilead Sciences, Inc.)

  The FDA granted original approval to Cayston (aztreonam for inhalation solution) from Gilead for the treatment of cystic fibrosis patients c…