Psoriasis

• FDA approval · 2024-05-21
  FDA Approved: CYCLOSPORINE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s cyclosporine as a generic drug under an original ANDA (ANDA209811).

• FDA approval · 2024-04-10
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Betamethasone dipropionate topical from Aurobindo Pharma Limited under an original ANDA for inflammatory and pruritic corticost…

• FDA approval · 2024-01-08
  FDA Approved: METHOXSALEN — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for methoxsalen submitted by Strides Pharma Science Limited. This action updates the approved la…

• FDA approval · 2023-12-28
  FDA Approved: CLOBETASOL PROPIONATE ANDA — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved the original ANDA for clobetasol propionate topical from Macleods Pharmaceuticals Limited, enabling a generic version of th…

• FDA approval · 2023-12-14
  FDA Approved: CYCLOSPORINE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva Pharmaceuticals' generic cyclosporine under an original application (ANDA 203880), expanding access to this immunosuppress…

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• FDA approval · 2022-11-29
  FDA Approved: JYLAMVO — Original Application (SHORLA ONCOLOGY INC.)

  FDA approved JYLAMVO (methotrexate) under an Original Application from SHORLA ONCOLOGY INC.

• FDA approval · 2022-02-18
  FDA Approved: BETAMETHASONE DIPROPIONATE USP, 0.05% — Original Application (TruPharma LLC)

  FDA approved the Original Application for Betamethasone Dipropionate USP, 0.05% (topical corticosteroid) submitted by TruPharma LLC. It is a…

• FDA approval · 2022-02-02
  FDA Approved: CYCLOSPORINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' original application for cyclosporine, a generic immunosuppressant product. This makes a generic cyc…

• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc. (ANDA089342).

• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.

• FDA approval · 2021-06-14
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  The FDA approved a supplemental application for TREXALL (methotrexate) filed by Teva Women's Health, Inc.

• FDA approval · 2021-04-02
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Quagen Pharmaceuticals LLC)

  FDA approved the Original Application for fluocinonide acetonide topical product. The generic is manufactured by Quagen Pharmaceuticals LLC.

• FDA approval · 2021-02-05
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves a generic Triamcinolone Acetonide topical product under an Original Application (ANDA) for Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2020-08-07
  FDA Approved: ACITRETIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Acitretin from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2020-07-17
  FDA Approved: VECTICAL — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for VECTICAL (calcitriol) from Galderma Laboratories to expand its labeling for use in psoriasis…

• FDA approval · 2020-07-14
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved the original application for Betamethasone Dipropionate by Viona Pharmaceuticals Inc, granting it as a generic topical corticos…

• FDA approval · 2020-07-07
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The U.S. FDA approved a supplemental application for betamethasone dipropionate from Glenmark Pharmaceuticals Inc., USA. This action adds re…

• FDA approval · 2020-06-25
  FDA Approved: ACITRETIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for ACITRETIN from Mylan Pharmaceuticals Inc., resulting in updated labeling.

• FDA approval · 2020-06-17
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original application for Betamethasone Dipropionate topical, a potent corticosteroid for inflammatory …

• FDA approval · 2020-06-15
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Betamethasone Dipropionate from E. Fougera & Co., indicating an approval related to the gene…

• FDA approval · 2020-06-09
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Betamethasone Dipropionate by Actavis Pharma, Inc., indicating an update to the product's approv…

• FDA approval · 2020-06-01
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's Triamcinolone acetonide via an Original Application (ANDA) for a generic formulation.

• FDA approval · 2020-03-04
  FDA Approved: HYDROCORTISONE VALERATE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved the original application for hydrocortisone valerate by Cosette Pharmaceuticals, Inc., establishing a new generic topical corti…

• FDA approval · 2020-02-10
  FDA Approved: FLUOCINONIDE — Original Application (Zydus Lifesciences Limited)

  The FDA approved the original application for a generic fluocinolone topical product from Zydus Lifesciences Limited. The approval confirms …

• FDA approval · 2020-01-30
  FDA Approved: METHOTREXATE — Original Application (Chartwell RX, LLC)

  FDA approvedChartwell RX, LLC's methotrexate product under an Original Application, making a new generic version of methotrexate available. …