Irritable Bowel Syndrome with Constipation

• FDA label_change · 2025-11-04
  FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)

  FDA supplemental application for Linzess (linaclotide) submitted by Allergan to modify labeling.

• FDA label_change · 2022-04-05
  FDA Approved: IBSRELA — Supplemental Application (Ardelyx, Inc.)

  FDA approved a supplemental application for IBSRELA (tenapanor hydrochloride) submitted by Ardelyx, updating the drug labeling.

• FDA label_change · 2017-08-01
  FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Lubiprostone filed by Dr. Reddy's Laboratories to update the product labeling with expanded indi…