Crohn Disease

• FDA approval · 2025-04-30
  FDA Approved: SELARSDI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for SELARSDI (ustekinumab-aekn) from Teva Pharmaceuticals USA, Inc., representing an approval of a b…

• FDA approval · 2025-04-30
  FDA Approved: OTULFI — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for OTULFI (ustekinumab-aauz) from Fresenius Kabi USA, LLC.

• FDA approval · 2025-04-30
  FDA Approved: STEQEYMA — Original Application (CELLTRION USA, Inc.)

  The FDA approved STEQEYMA (ustekinumab-stba) from Celltrion USA, Inc. under an Original Biologics License Application.

• FDA approval · 2025-04-30
  FDA Approved: YESINTEK — Original Application (Biocon Biologics Inc.)

  The FDA approved Yesintek (ustekinumab) from Biocon Biologics Inc. under an original Biologics License Application. It is indicated for plaq…

• FDA approval · 2025-04-30
  FDA Approved: OTULFI — Original Application (Fresenius Kabi USA, LLC)

  OTULFI (USTEKINUMAB-AAUZ) received FDA approval under an Original Application from Fresenius Kabi USA, LLC.

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• FDA approval · 2025-04-28
  FDA Approved: STEQEYMA — Supplemental Application (CELLTRION USA, Inc.)

  The FDA approved a supplemental application for STEQEYMA (ustekinumab-stba) from Celltrion USA, Inc.

• FDA approval · 2025-04-14
  FDA Approved: OTULFI — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental Biologics License Application for OTULFI (ustekinumab-AAUZ) from Fresenius Kabi USA, LLC.

• FDA approval · 2025-04-07
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  FDA approved a supplemental application for ADALIMUMAB-AATY, a biosimilar adalimumab from Celltrion USA, Inc., in connection with its regula…

• FDA approval · 2025-04-01
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) by Janssen Biotech, Inc.

• FDA approval · 2025-03-18
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for TYSABRI (natalizumab), leading to labeling changes under a supplemental submission. The d…

• FDA approval · 2025-03-13
  FDA Approved: USTEKINUMAB-TTWE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC, updating the product’s labeling a…

• FDA approval · 2025-03-06
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Mesalamine submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-02-18
  FDA Approved: MESALAMINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's original ANDA for Mesalamine, a generic mesalamine product. This approval authorizes marketing for ulcerative colitis,…

• FDA approval · 2025-02-13
  FDA Approved: PREDNISOLONE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental Abbreviated New Drug Application for a generic prednisolone product from PAI Holdings/PAI Pharma, signaling regu…

• FDA approval · 2025-02-12
  FDA Approved: SELARSDI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for SELARSDI (ustekinumab-aeKn) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-01-15
  FDA Approved: OMVOH — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for OMVOH (mirikizumab-MRKZ) submitted by Eli Lilly and Company.

• FDA approval · 2024-12-26
  FDA Approved: WEZLANA — Supplemental Application (Nuvaila Limited)

  The FDA approved a supplemental Biologics License Application for WEZLANA (ustekinumab-auub) submitted by Nuvaila Limited.

• FDA approval · 2024-12-20
  FDA Approved: USTEKINUMAB-TTWE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC. This action confirms additional regul…

• FDA approval · 2024-12-18
  FDA Approved: IDACIO — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for IDACIO (adalimumab-aacf) from Fresenius Kabi USA, LLC.

• FDA approval · 2024-12-17
  FDA Approved: STEQEYMA — Original Application (CELLTRION USA, Inc.)

  FDA approved STEQEYMA (ustekinumab-stba) from Celltrion USA as a biosimilar to ustekinumab under an original biologics license application. …

• FDA approval · 2024-11-29
  FDA Approved: YESINTEK — Original Application (Biocon Biologics Inc.)

  FDA approved Yesintek (ustekinumab) from Biocon Biologics Inc. under an Original Application. It covers the established ustekinumab indicati…

• FDA approval · 2024-10-10
  FDA Approved: IMULDOSA — Original Application (Accord BioPharma Inc.)

  The FDA approves Imuldosa (ustekinumab-srlf) from Accord BioPharma Inc. under an Original Biologics License Application, expanding treatment…

• FDA approval · 2024-09-27
  FDA Approved: OTULFI — Original Application (Fresenius Kabi USA, LLC)

  FDA approved OTULFI (ustekinumab-aauz) from Fresenius Kabi USA, LLC, as an original application. OTULFI is a monoclonal antibody targeting I…

• FDA approval · 2024-08-26
  FDA Approved: ADALIMUMAB-RYVK — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for ADALIMUMAB-RYVK, a biosimilar to adalimumab, submitted by Quallent Pharmaceuticals Health LL…

• FDA approval · 2024-07-30
  FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for MESALAMINE from ANI Pharmaceuticals, Inc.