Plaque Psoriasis

• FDA label_change · 2026-02-27
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

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

• FDA label_change · 2025-05-22
  FDA Approved: ZORYVE — Supplemental Application (Arcutis Biotherapeutics, Inc.)

  FDA notes a supplemental application for ZORYVE (roflumilast) by Arcutis Biotherapeutics to update the product label, likely to add or modif…

• FDA label_change · 2024-07-02
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for SILIQ (brodalumab) submitted by Bausch Health US LLC to update the product labeling. The action …

• FDA label_change · 2021-08-06
  FDA Approved: ENSTILAR — Supplemental Application (LEO Pharma Inc.)

  FDA approved a supplemental application for ENSTILAR (calcipotriene and betamethone dipropionate) from LEO Pharma Inc., resulting in changes…

• FDA label_change · 2019-12-26
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  FDA approved a supplemental application for OTREXUP (methotrexate) from Antares Pharma, Inc., leading to changes in the labeling for this su…

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• FDA label_change · 2019-07-25
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  The FDA approved a supplemental application for TACLONEX (calcipotriol and betamethone dipropionate) from LEO Pharma Inc., resulting in chan…

• FDA label_change · 2019-01-29
  FDA Approved: TREMFYA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for TREMFYA (guselkumab) by Janssen Biotech, Inc., resulting in changes to the labeling.

• FDA label_change · 2018-04-16
  FDA Approved: TAZORAC — Supplemental Application (Almirall, LLC)

  The FDA approved a supplemental application for TAZORAC (tazarotene) from Almirall, updating the product’s labeling.

• FDA label_change · 2017-06-08
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

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

• FDA label_change · 2016-03-08
  FDA Approved: ENSTILAR — Supplemental Application (LEO Pharma Inc.)

  The FDA approved a supplemental labeling application for ENSTILAR (calcipotriene and betamethone dipropionate) from LEO Pharma Inc., resulti…

• FDA label_change · 2015-06-29
  FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for clobetasol propionate from Actavis Pharma, Inc. to update the product labeling.

• FDA label_change · 2015-04-27
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  FDA announces that Amgen's supplemental application for OTEZLA (apremilast) has been approved, updating the product labeling accordingly.

• FDA label_change · 2014-02-26
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  FDA approves a supplemental application for Taclonex (calcipotriol and betamethone dipropionate) from LEO Pharma Inc., updating the product …

• FDA label_change · 2012-11-30
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  The FDA approved a supplemental application for Taclonex (calcipotriene and betamethone dipropionate) submitted by LEO Pharma Inc., resultin…

• FDA label_change · 2012-10-17
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  FDA approved a supplemental application for Taclonex (calcipotriene and betamethasone dipropionate) from LEO Pharma, resulting in a label up…

• FDA label_change · 2012-09-07
  FDA Approved: CLOBEX — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for CLOBEX (clobetasol propionate) from Galderma Laboratories, L.P. The approval updates the product…