Ulcerative Colitis

• EMA label_change · 2026-03-23
  EMA Authorised: Tremfya — Janssen-Cilag International NV

  EU authorises Tremfya to treat psoriasis, Crohn's disease, and ulcerative colitis.

• FDA label_change · 2025-08-12
  FDA Approved: VELSIPITY — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for VELSIPITY (etrasimod) to update the product label, including changes to indications, dosing, or …

• FDA label_change · 2025-06-27
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for Ustekinumab (Stelara) by Janssen Biotech, resulting in updated labeling.

• FDA label_change · 2025-03-26
  FDA Approved: RINVOQ — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie’s supplemental application for Rinvoq (upadacitinib), resulting in a labeling update for the product.

• FDA label_change · 2024-07-30
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, Inc., updating the product labeling.

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• FDA label_change · 2023-05-01
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for mesalamine submitted by Zydus Lifesciences Limited, typically indicating a labeling update o…

• FDA label_change · 2022-11-16
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for mesalamine from Teva Pharmaceuticals USA to update the product labeling.

• FDA label_change · 2020-10-01
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental labeling/approval for CANASA (mesalamine) from Allergan, Inc.

• FDA label_change · 2020-05-19
  FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA has approved Sun Pharmaceutical's supplemental application for mesalamine, likely resulting in changes to the product labeling.

• FDA label_change · 2017-08-22
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for PENTASA (mesalamine) submitted by Takeda Pharmaceuticals America, resulting in an update to the …

• FDA label_change · 2017-08-22
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc. This approval results in chang…

• FDA label_change · 2015-08-05
  FDA Approved: SIMPONI ARIA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Simponi Aria (golimumab) filed by Janssen Biotech, Inc., resulting in changes to the product lab…

• FDA label_change · 2015-02-25
  FDA Approved: SULFASALAZINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for sulfasalazine from Teva Pharmaceuticals USA, updating the product labeling.

• FDA label_change · 2013-12-16
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for PENTASA (mesalamine) to update the product labeling. The submission was filed by Takeda Pharmace…

• FDA label_change · 2013-12-16
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, resulting in updated labeling.

• FDA label_change · 2009-10-30
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for LIALDA (mesalamine) submitted by Takeda Pharmaceuticals America, Inc.