Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-04-06FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) filed by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2016-03-18FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves a supplemental application for ORKAMBI (lumacaftor/ivacaftor) by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2016-01-10FDA Approved: ACETYLCYSTEINE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Acetylcysteine from Fresenius Kabi USA, LLC, under an ANDA.
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FDA approval · 2016-01-06FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for TOBI PODHALER (tobramycin) from Viatris Specialty LLC.
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FDA approval · 2015-12-28FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) filed by Gilead Sciences, Inc., resulting in updated labeling.
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FDA approval · 2015-11-24FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated.
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FDA approval · 2015-10-05FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI (tobramycin) submitted by Viatris Specialty LLC.
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FDA approval · 2015-10-02FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI PODHALER (tobramycin) from Viatris Specialty LLC. The action relates to the continued use o…
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FDA approval · 2015-09-11FDA 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.
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FDA approval · 2015-09-01FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. This action updates t…
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FDA approval · 2015-07-02FDA Approved: ORKAMBI — Original Application (Vertex Pharmaceuticals Incorporated)
FDA approval of ORKAMBI (lumacaftor and ivacaftor) under an original application by Vertex Pharmaceuticals for cystic fibrosis.
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FDA approval · 2015-04-14FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI (tobramycin inhalation solution) from Viatris Specialty LLC, approving changes to the produ…
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FDA approval · 2015-04-10FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc.
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FDA approval · 2015-03-17FDA Approved: KALYDECO — Original Application (Vertex Pharmaceuticals Incorporated)
The FDA granted original approval of KALYDECO (ivacaftor) from Vertex Pharmaceuticals under NDA 207925. It is approved for the treatment of …
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FDA approval · 2015-03-09FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated, resulting in changes to the d…
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FDA approval · 2015-03-04FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals, resulting in updated labeling for …
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FDA approval · 2015-03-03FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
The FDA approved a supplemental application for PANCREAZE (pancrelipase) from VIVUS LLC.
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FDA approval · 2015-02-16FDA Approved: TOBRAMYCIN INHALATION — Supplemental Application (Prasco, LLC)
The FDA approved a supplemental application for Tobramycin Inhalation submitted by Prasco, LLC, signaling regulatory clearance for this inha…
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FDA approval · 2015-01-12FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) by Gilead Sciences, Inc.
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FDA approval · 2015-01-05FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating its labeling to support its use for exocrine panc…
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FDA approval · 2015-01-05FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated. This action updates the existing …
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FDA approval · 2014-12-29FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.
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FDA approval · 2014-12-12FDA Approved: PULMOZYME — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Pulmozyme (dornase alfa) filed by Genentech, Inc.
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FDA approval · 2014-12-11FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. The approval updates the …
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FDA approval · 2014-12-02FDA 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…