Irritable Bowel Syndrome with Constipation

• FDA approval · 2025-05-20
  FDA Approved: IBSRELA — Supplemental Application (Ardelyx, Inc.)

  The FDA approved a supplemental application for IBSRELA (tenapanor hydrochloride) submitted by Ardelyx, Inc., under NDA 211801.

• FDA approval · 2025-01-10
  FDA Approved: IBSRELA — Supplemental Application (Ardelyx, Inc.)

  FDA approved a supplemental application for IBSRELA (tenapanor hydrochloride) from Ardelyx, Inc.

• FDA approval · 2025-01-02
  FDA Approved: LUBIPROSTONE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original generic application for lubiprostone to treat chronic idiopathic constipation, opioid-induced …

• FDA approval · 2023-06-12
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Linzess (linaclotide) submitted by Allergan.

• FDA approval · 2023-03-23
  FDA Approved: LUBIPROSTONE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for lubiprostone from Zydus Pharmaceuticals USA Inc., establishing a generic version of Lubiprostone. …

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• FDA approval · 2022-01-18
  FDA Approved: LUBIPROSTONE — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva's Lubiprostone generic under an original application (ANDA 209920). This marks approval of a generic version of lubipr…

• FDA approval · 2021-05-19
  FDA Approved: IBSRELA — Supplemental Application (Ardelyx, Inc.)

  The FDA approved a supplemental application for IBSRELA (tenapanor hydrochloride) from Ardelyx, Inc., likely updating labeling or expanding …

• FDA approval · 2021-04-12
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Linzess (linaclotide) from Allergan, Inc., to update/expand its label.

• FDA approval · 2021-03-05
  FDA Approved: IBSRELA — Supplemental Application (Ardelyx, Inc.)

  Ardelyx submitted a supplemental application to the FDA for IBSRELA (tenapanor hydrochloride) related to its labeling for irritable bowel sy…

• FDA approval · 2021-02-10
  FDA Approved: TRULANCE IMMEDIATE RELEASE — Supplemental Application (Salix Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Trulance Immediate Release (plecanatide) submitted by Salix Pharmaceuticals.

• FDA approval · 2020-11-30
  FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for Lubiprostone submitted by Dr. Reddy's Laboratories, updating labeling under NDA 021908.

• FDA approval · 2020-10-29
  FDA Approved: TRULANCE IMMEDIATE RELEASE — Supplemental Application (Salix Pharmaceuticals Inc.)

  FDA approved a supplemental application to introduce an immediate-release formulation of Trulance (plecanatide) produced by Salix Pharmaceut…

• FDA approval · 2020-09-22
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for Linzess (linaclotide), submitted by Allergan, Inc.

• FDA approval · 2019-09-12
  FDA Approved: IBSRELA — Original Application (Ardelyx, Inc.)

  The FDA approved IBSRELA (tenapanor hydrochloride) in an original NDA for the treatment of irritable bowel syndrome with constipation. This …

• FDA approval · 2018-07-25
  FDA Approved: TRULANCE IMMEDIATE RELEASE — Supplemental Application (Salix Pharmaceuticals Inc.)

  The FDA approved a Supplemental Application for TRULANCE IMMEDIATE RELEASE (plecanatide) from Salix Pharmaceuticals Inc. This action concern…

• FDA approval · 2018-04-26
  FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Lubiprostone filed by Dr. Reddy's Laboratories Inc.

• FDA approval · 2018-01-24
  FDA Approved: TRULANCE IMMEDIATE RELEASE — Supplemental Application (Salix Pharmaceuticals Inc.)

  FDA approved a supplemental application for an immediate-release formulation of Trulance (plecanatide) from Salix Pharmaceuticals, expanding…

• FDA approval · 2017-01-19
  FDA Approved: TRULANCE IMMEDIATE RELEASE — Original Application (Salix Pharmaceuticals Inc.)

  The FDA approved Trulance immediate-release (plecanatide) from Salix Pharmaceuticals in an original NDA for the treatment of chronic idiopat…

• FDA approval · 2017-01-06
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Linzess (linaclotide) filed by Allergan, expanding its regulatory status.

• FDA approval · 2016-10-11
  FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Lubiprostone from Dr. Reddy's Laboratories Inc., typically reflecting updates to labeling or ind…

• FDA approval · 2016-05-18
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  FDA has approved a supplemental application for Linzess (linaclotide) from Allergan, expanding the labeling for the product.

• FDA approval · 2016-04-06
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for LINZESS (linaclotide).

• FDA approval · 2015-11-23
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for LINZESS (linaclotide) submitted by Allergan, Inc. This action updates the regulatory status …

• FDA approval · 2015-01-05
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Linzess (linaclotide) from Allergan, Inc., indicating agency approval of a supplemental NDA …

• FDA approval · 2014-12-11
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Linzess (linaclotide) from Allergan, expanding its labeling.