Cystic Fibrosis

• EMA label_change · 2025-02-28
  Combination of cystic fibrosis medicines to treat patients with rare mutations

  EMA issued a positive opinion to extend the indication of cystic fibrosis modulator medicines so that all patients with modulator-responsive…

• FDA label_change · 2020-01-28
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  FDA approved a supplemental application for Pancreaze (pancrelipase enzyme mix) from VIVUS LLC.

• FDA label_change · 2017-05-17
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  FDA approved a supplemental application for KALYDECO (ivacaftor), resulting in a label change for the drug.

• FDA label_change · 2017-01-27
  FDA Approved: TOBI PODHALER — Supplemental Application (Viatris Specialty LLC)

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

• FDA label_change · 2017-01-11
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex, resulting in changes to the drug's labeling.

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• FDA label_change · 2016-05-20
  FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

  FDA approved a supplemental application for KALYDECO (ivacaftor) from Vertex Pharmaceuticals Incorporated, resulting in a label change. The …

• FDA label_change · 2014-11-21
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating the labeling to reflect approved uses for exocrine pa…

• FDA label_change · 2011-06-15
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, resulting in changes to the product lab…