Pancreatitis

• FDA approval · 2024-02-28
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  FDA approved a supplemental application for PERTZYE (pancrelipase) submitted by Digestive Care, Inc.

• FDA approval · 2024-02-28
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  FDA approved a supplemental application for PANCREAZE, a pancreatic enzyme replacement product, submitted by VIVUS LLC.

• FDA approval · 2023-11-20
  FDA Approved: VIOKACE — Supplemental Application (Aimmune Therapeutics, Inc.)

  FDA approved a supplemental application for VIOKACE (pancrelipase) to update and expand its labeling. The action supports additional indicat…

• FDA approval · 2023-10-27
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, Inc., updating its labeling for exo…

• FDA approval · 2023-03-24
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fenofibrate submitted by Mylan Pharmaceuticals Inc., for a generic fenofibrate product.

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• FDA approval · 2022-09-28
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., approving changes to the product's labeling. P…

• FDA approval · 2022-05-25
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals’ supplemental application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

• FDA approval · 2021-04-26
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  The FDA approved a supplemental application for Pancreaze (pancrelipase) from VIVUS LLC, updating its labeling and/or indications.

• 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 · 2017-07-12
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  The FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc.

• FDA approval · 2016-12-19
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, Inc.

• FDA approval · 2016-10-06
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  FDA Supplemental Application for PERTZYE (pancrelipase) submitted by Digestive Care, Inc. under BLA022175. The submission pertains to a supp…

• FDA approval · 2016-06-16
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved AbbVie's supplemental application for CREON (pancrelipase), updating its labeling to reflect expanded indications for exocr…

• FDA approval · 2016-05-16
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  FDA approved a supplemental application for Pancreaze (pancrelipase) by VIVUS LLC, expanding labeling/indications related to exocrine pancre…

• FDA approval · 2016-02-19
  FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Gemfibrozil filed by Chartwell RX, LLC under an existing ANDA, indicating regulatory approval re…

• FDA approval · 2015-04-10
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2015-03-03
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  The FDA approved a supplemental application for PANCREAZE (pancrelipase) from VIVUS LLC.

• FDA approval · 2015-01-05
  FDA 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…

• FDA approval · 2014-11-19
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-09-26
  FDA 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/…

• FDA approval · 2014-03-07
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

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

• FDA approval · 2014-01-23
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  FDA approves a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., expanding its labeling/indication.