Cystic Fibrosis

• 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 · 2012-12-07
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  The FDA granted a supplemental approval for PANCREAZE (pancrelipase) to VIVUS LLC.

• FDA approval · 2012-11-20
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) submitted by AbbVie Inc. The action involves modifications to the produ…

• FDA approval · 2012-10-12
  FDA Approved: TOBRAMYCIN INHALATION — Original Application (Prasco, LLC)

  The FDA approved an Original Application for Tobramycin Inhalation by Prasco, LLC, for the treatment of chronic Pseudomonas aeruginosa infec…

• FDA approval · 2012-09-24
  FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Cayston (aztreonam) submitted by Gilead Sciences. This action updates the product’s labeling…

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• FDA approval · 2012-08-28
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  FDA approved a supplemental application for KALYDECO (ivacaftor) by Vertex Pharmaceuticals Incorporated, resulting in an updated regulatory …

• EMA approval · 2012-05-25
  European Medicines Agency recommends first-in-class medicine for treatment of cystic fibrosis

  EMA recommends a first-in-class medicine for treating cystic fibrosis, indicating a pivotal recommendation toward approval for a new mechani…

• FDA approval · 2012-05-17
  FDA Approved: PERTZYE — Original Application (Digestive Care, Inc.)

  PERTZYE (pancrelipase) was approved on an original application for the treatment of exocrine pancreatic insufficiency.

• FDA approval · 2012-03-01
  FDA Approved: VIOKACE — Original Application (Aimmune Therapeutics, Inc.)

  FDA approved Viokace (pancrelipase) via an original application from Aimmune Therapeutics, establishing a pancrelipase therapy for exocrine …

• CLINICAL_TRIALS approval · 2012-02-09
  Clinical Trial Update: VX-770 Expanded Access Program

  Ivacaftor (VX-770) has received marketing approval for cystic fibrosis, as noted in Vertex's expanded access program update.

• FDA approval · 2012-01-31
  FDA Approved: KALYDECO — Original Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved KALYDECO (ivacaftor) through an original application for the treatment of cystic fibrosis in patients with specific CFTR ga…

• CLINICAL_TRIALS approval · 2011-08-02
  Clinical Trial Update: Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

  Aztreonam lysine for inhalation has been approved for use in patients with cystic fibrosis who have Pseudomonas aeruginosa airway infection.…

• FDA approval · 2011-07-13
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  The FDA approved a supplemental application for Zenpep (pancrelipase) submitted by Aimmune Therapeutics, authorizing changes to labeling rel…

• FDA approval · 2011-07-12
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc., updating its labeling to reflect indications for exoc…

• FDA approval · 2011-06-10
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie.

• FDA approval · 2010-10-06
  FDA Approved: PULMOZYME — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Pulmozyme (dornase alfa) from Genentech, Inc., under the original Biologics License Application.

• FDA approval · 2010-08-20
  FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Cayston (aztreonam) from Gilead Sciences, Inc. The approval updates Cayston’s labeling.

• FDA approval · 2010-08-12
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating its labeling/indication as part of a supplemental…

• FDA approval · 2010-04-30
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for CREON (pancrelipase) submitted by AbbVie.

• 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…

• FDA approval · 2009-08-27
  FDA Approved: ZENPEP — Original Application (Aimmune Therapeutics, Inc.)

  FDA approves Zenpep (pancrelipase) in an Original Application for the treatment of exocrine pancreatic insufficiency due to conditions such …

• FDA approval · 2009-04-30
  FDA Approved: CREON — Original Application (AbbVie Inc.)

  FDA approved CREON (pancrelipase) under AbbVie’s original Biologics License Application, authorizing its marketing for exocrine pancreatic i…

• FDA approval · 2008-10-16
  FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for TOBI (tobramycin) submitted by Viatris Specialty LLC.

• FDA approval · 2008-03-11
  FDA Approved: TOBRAMYCIN — Original Application (Mylan Institutional LLC)

  The FDA approved an original application for a generic Tobramycin product (TOBRAMYCIN) from Mylan Institutional LLC.