Cystic Fibrosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-11-19FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc.
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FDA approval · 2014-11-10FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated, resulting in updated labeling…
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FDA approval · 2014-11-10FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) submitted by Gilead Sciences, Inc., marking approval of an updated or expand…
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FDA approval · 2014-10-24FDA Approved: TOBRAMYCIN — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for tobramycin by Mylan Institutional LLC (ANDA065407). This action approves the generic tobramycin …
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FDA approval · 2014-09-30FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
FDA approval of a supplemental application for TOBI Podhaler (tobramycin) submitted by Viatris Specialty LLC.
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FDA approval · 2014-09-26FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for Zenpep (pancrelipase) submitted by Aimmune Therapeutics, expanding or updating its labeling/…
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FDA approval · 2014-07-29FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. The approval covers c…
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FDA approval · 2014-07-09FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) submitted by Gilead Sciences, Inc.
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FDA approval · 2014-06-13FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. The action updates th…
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FDA approval · 2014-05-19FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Cayston (aztreonam) by Gilead Sciences, Inc. This action updates the existing approval for Cayst…
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FDA approval · 2014-04-25FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for TOBI (tobramycin inhalation solution) from Viatris Specialty LLC.
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FDA approval · 2014-04-25FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for TOBI Podhaler (tobramycin inhalation powder) from Viatris Specialty LLC.
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FDA approval · 2014-04-08FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. The action updates the pr…
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FDA approval · 2014-03-07FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for PANCREAZE (pancrelipase) submitted by VIVUS LLC.
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FDA approval · 2014-02-21FDA 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 · 2014-01-23FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
FDA approves a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., expanding its labeling/indication.
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FDA approval · 2014-01-07FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for TOBI PODHALER (tobramycin) by Viatris Specialty LLC.
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FDA approval · 2013-12-13FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated. This action represent…
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FDA approval · 2013-12-09FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics.
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FDA approval · 2013-10-24FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for TOBI (tobramycin inhalation solution) submitted by Viatris Specialty LLC.
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FDA approval · 2013-09-26FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for TOBI (tobramycin) submitted by Viatris Specialty LLC.
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FDA approval · 2013-06-03FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)
FDA approves Vertex's supplemental application for KALYDECO (ivacaftor), resulting in updated labeling for additional cystic fibrosis indica…
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FDA approval · 2013-04-11FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics.
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FDA approval · 2013-03-22FDA 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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FDA approval · 2013-03-14FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for CREON (pancrelipase) by AbbVie.