Plaque Psoriasis

• FDA approval · 2024-04-16
  FDA Approved: SELARSDI — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved SELARSDI (USTEKINUMAB-AEKN) from Teva Pharmaceuticals USA, Inc. under an original Biologics License Application (BLA 761343).

• FDA approval · 2024-04-03
  FDA Approved: ILUMYA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ILUMYA (tildrakizumab-asmn) filed by Sun Pharmaceutical Industries, expanding or modifying its r…

• FDA approval · 2024-03-18
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab submitted by Janssen Biotech, Inc.

• FDA approval · 2024-02-22
  FDA Approved: ZYMFENTRA — Supplemental Application (CELLTRION USA Inc.)

  The FDA approved a supplemental application for ZYMFENTRA (infliximab-dyyb) submitted by Celltrion USA Inc.

• FDA approval · 2023-12-26
  FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.

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• FDA approval · 2023-12-15
  FDA Approved: ZORYVE — Original Application (Arcutis Biotherapeutics, Inc.)

  FDA approved ZORYVE (roflumilast) topical cream as an original application for treating plaque psoriasis.

• FDA approval · 2023-12-15
  FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)

  The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).

• FDA approval · 2023-11-30
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  The FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, Inc., allowi…

• FDA approval · 2023-11-29
  FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's supplemental application for clobetasol propionate, a potent topical corticosteroid, enabling an approved supplement…

• FDA approval · 2023-11-21
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals, incorporating changes to the a…

• FDA approval · 2023-11-20
  FDA Tentative Approval: TALTZ — Supplemental Application (Eli Lilly and Company)

  The FDA issued tentative approval for a supplemental application for TALTZ (ixekizumab) by Eli Lilly, indicating the submission is approvabl…

• FDA approval · 2023-11-03
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  FDA approved WEZLANA (ustekinumab-auub) from Nuvaila Limited under an original Biologics License Application.

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  This entry documents the original Biologics License Application for WEZLANA, a ustekinumab-AUUB monoclonal antibody developed by Nuvaila Lim…

• FDA approval · 2023-10-20
  FDA Approved: ZYMFENTRA — Original Application (CELLTRION USA Inc.)

  FDA approved ZYMFENTRA (inflximab-dyyb) from Celltrion USA as a biosimilar to infliximab (Remicade), based on demonstration of biosimilarity…

• FDA approval · 2023-10-18
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2023-10-17
  FDA Approved: BIMZELX — Original Application (UCB, Inc.)

  FDA approved BIMZELX (bimekizumab) from UCB, Inc. via an original biologics license application, marking the first approval of this monoclon…

• FDA approval · 2023-10-06
  FDA Approved: COSENTYX — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved the original application for Cosentyx (secukinumab), a monoclonal antibody targeting IL-17A, for the treatment of plaque psoria…

• FDA approval · 2023-10-06
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-09-21
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…

• FDA approval · 2023-08-23
  FDA Approved: DESOXIMETASONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for desoximetasone from Padagis Israel Pharmaceuticals Ltd, finalizing an update to the approved AND…

• FDA approval · 2023-08-11
  FDA Approved: LEXETTE — Original Application (Mayne Pharma)

  FDA approved Mayne Pharma's original application for halobetasol propionate under the brand LEXETTE.

• FDA approval · 2023-07-24
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-07-19
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

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

• FDA approval · 2023-07-19
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar of adalimumab from Quallent Pharmaceuticals Health LLC.