Cystic Fibrosis

• FDA approval · 2020-12-21
  FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved a supplemental application for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals Incorporated…

• FDA approval · 2020-11-18
  FDA Approved: TRIKAFTA — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  FDA supplemental approval action for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals; this action updates th…

• FDA approval · 2020-09-24
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.

• FDA approval · 2020-09-24
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated.

• FDA approval · 2020-07-13
  FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for TOBI PODHALER (tobramycin) from Viatris Specialty LLC. The approval updates the product’s labeli…

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• EMA approval · 2020-06-26
  New medicine for cystic fibrosis patients

  EMA announces a new medicine for cystic fibrosis patients, signaling an important approval or landmark development for CF treatment in Europ…

• FDA approval · 2020-03-20
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, updating the labeling related to it…

• FDA approval · 2020-03-20
  FDA Approved: VIOKACE — Supplemental Application (Aimmune Therapeutics, Inc.)

  FDA approved a supplemental application for Viokace (pancrelipase) by Aimmune Therapeutics, expanding its labeling for exocrine pancreatic i…

• FDA approval · 2020-03-20
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  The FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., updating its labeling under the supplement…

• FDA approval · 2020-03-20
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  FDA approved a supplemental application for Pancreaze (pancrelipase) submitted by VIVUS LLC.

• FDA approval · 2020-02-20
  FDA Approved: TOBRAMYCIN INHALATION SOLUTION — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for Dr. Reddy's Tobramycin Inhalation Solution, granting generic approval for this inhaled antib…

• FDA approval · 2019-12-27
  FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  FDA approved a supplemental application for Symdeko (tezacaftor/ivacaftor) submitted by Vertex Pharmaceuticals.

• FDA approval · 2019-12-09
  FDA Approved: TOBRAMYCIN INHALATION — Supplemental Application (Prasco, LLC)

  The FDA approved a supplemental application for Tobramycin Inhalation by Prasco, LLC, expanding the approved labeling for the product.

• FDA approval · 2019-12-06
  FDA Approved: TOBRAMYCIN INHALATION SOLUTION PAK — Supplemental Application (Genericus, Inc.)

  FDA approved a supplemental application to authorize Genericus, Inc. to market a generic tobramycin inhalation solution PAK.

• FDA approval · 2019-11-20
  FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2019-10-21
  FDA Approved: TRIKAFTA — Original Application (Vertex Pharmaceuticals Incorporated)

  FDA approved TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) as the original application for the treatment of cystic fibrosis. It represents a p…

• FDA approval · 2019-06-26
  FDA Approved: TOBRAMYCIN — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's Tobramycin generic under an Original Application (ANDA). The approval makes this generic Tobramycin available as a t…

• FDA approval · 2019-06-21
  FDA Approved: SYMDEKO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved Vertex's supplemental application for Symdeko (tezacaftor/ivacaftor), resulting in an updated/expanded label.

• FDA approval · 2019-04-29
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated. The action involves changes t…

• FDA approval · 2019-04-29
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals, indicating an expansion or modification of…

• FDA approval · 2019-02-11
  FDA Approved: CAYSTON — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2018-12-20
  FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2018-10-05
  FDA Approved: TOBI — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2018-08-15
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

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

• FDA approval · 2018-08-15
  FDA Approved: ORKAMBI — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) submitted by Vertex Pharmaceuticals Incorporated.