Plaque Psoriasis

• 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 · 2025-03-13
  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 · 2025-03-10
  FDA Approved: TAZAROTENE — Supplemental Application (Mayne Pharma)

  The FDA approved a supplemental application for tazarotene submitted by Mayne Pharma, extending its approved use.

• 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 · 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 · 2024-09-11
  FDA Approved: TREMFYA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for TREMFYA (guselkumab) submitted by Janssen Biotech, Inc., affecting the drug's approved labeling …

• 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 · 2024-08-12
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for SILIQ (brodalumab) submitted by Bausch Health US LLC.

• FDA approval · 2024-06-28
  FDA Approved: USTEKINUMAB-TTWE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a new biologic product, ustekinumab-tTWE, from Quallent Pharmaceuticals Health LLC, via an Original Biologics License Applicati…

• FDA approval · 2024-04-30
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ABRILADA (adalimumab-afzb) from Pfizer Laboratories Div Pfizer Inc, authorizing its use as a…

• FDA approval · 2024-04-25
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for OTEZLA (apremilast), resulting in an approved supplemental change to the product label…