Cutaneous T-cell Lymphoma

• EMA approval · 2025-08-12
  EMA Authorised: Targretin (bexarotene) — H.A.C. Pharma

  The European Medicines Agency authorised Targretin (bexarotene) for cutaneous T-cell lymphoma, with H.A.C. Pharma as the marketing authoriza…

• FDA approval · 2024-09-06
  FDA Approved: BEXAROTENE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for a generic Bexarotene product for the treatment of cutaneous T-cell lymphoma (CTCL). T…

• FDA approval · 2024-08-07
  FDA Approved: LYMPHIR — Original Application (Citius Pharmaceuticals, Inc.)

  FDA approved LYMPHIR (denileukin diftitox-CXDL) through an original application for the treatment of CD25-expressing cutaneous T-cell lympho…

• FDA approval · 2024-03-06
  FDA Approved: BEXAROTENE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for bexarotene from Mylan Pharmaceuticals Inc., marking regulatory approval of the supplemental subm…

• FDA approval · 2022-04-27
  FDA Approved: BEXAROTENE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original application for BEXAROTENE from Amneal Pharmaceuticals NY LLC.

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• FDA approval · 2021-10-12
  FDA Approved: ROMIDEPSIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original ANDA for romidepsin by Fresenius Kabi USA, LLC, providing a generic version of the cancer therapy for certain T-ce…

• FDA approval · 2021-03-19
  FDA Approved: UVADEX — Supplemental Application (Therakos LLC)

  FDA approved a supplemental application for UVADEX (methoxsalen) from Therakos LLC.

• FDA approval · 2021-01-14
  FDA Approved: BEXAROTENE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s original application for generic Bexarotene. The drug is indicated for the treatment of cutaneous T-cell…

• FDA approval · 2020-11-23
  FDA Approved: BEXAROTENE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Bexarotene from ANI Pharmaceuticals, updating the labeling for this product.

• FDA approval · 2020-05-01
  FDA Approved: VALCHLOR — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  The FDA approved a supplemental application for Valchlor (mechlorethamine hydrochloride) filed by Helsinn Therapeutics (U.S.), Inc. This act…

• FDA approval · 2018-12-11
  FDA Approved: ZOLINZA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ZOLINZA (vorinostat) from Merck Sharp & Dohme LLC.

• FDA approval · 2018-11-27
  FDA Approved: ISTODAX — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for Istodax (romidepsin) from Celgene Corporation. The action updates regulatory labeling for the dr…

• FDA approval · 2018-09-04
  FDA Approved: BEXAROTENE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original-application generic of Bexarotene for cutaneous T-cell lymphoma.

• FDA approval · 2018-07-25
  FDA Approved: BEXAROTENE — Original Application (Upsher-Smith Laboratories, Inc.)

  FDA approved an Original Application for bexarotene from Upsher-Smith Laboratories, Inc., signaling the availability of a generic bexarotene…

• FDA approval · 2018-05-08
  FDA Approved: BEXAROTENE — Original Application (ANI Pharmaceuticals, Inc.)

  ANI Pharmaceuticals received FDA approval for a generic bexarotene through an Original Application (ANDA). The product is indicated for the …

• FDA approval · 2016-07-27
  FDA Approved: ISTODAX — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for Istodax (romidepsin) from Celgene Corporation.

• FDA approval · 2016-04-08
  FDA Approved: VALCHLOR — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for Valchlor (mechlorethamine hydrochloride) from Helsinn Therapeutics (U.S.), Inc.

• FDA approval · 2015-12-17
  FDA Approved: ZOLINZA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Zolinza (vorinostat) from Merck Sharp & Dohme LLC.

• FDA approval · 2015-09-14
  FDA Approved: TARGRETIN — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for TARGRETIN (bexarotene) submitted by Bausch Health US, LLC.

• FDA approval · 2015-07-29
  FDA Approved: TARGRETIN — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for TARGRETIN (bexarotene) submitted by Bausch Health US, LLC. This action represents a supplemental…

• FDA approval · 2014-12-02
  FDA Approved: TARGRETIN — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for Targretin (bexarotene) submitted by Bausch Health US, LLC.

• FDA approval · 2014-10-15
  FDA Approved: ISTODAX — Supplemental Application (Celgene Corporation)

  The FDA approved a Celgene supplemental application for ISTODAX (romidepsin).

• FDA approval · 2014-08-12
  FDA Approved: BEXAROTENE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's generic bexarotene for use in cutaneous T-cell lymphoma, including mycosis fungoides and Sézary syndrome.

• FDA approval · 2014-07-09
  FDA Approved: VALCHLOR — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for VALCHLOR (mechlorethamine hydrochloride) from Helsinn Therapeutics (U.S.), Inc.

• FDA approval · 2013-08-23
  FDA Approved: VALCHLOR — Original Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved VALCHLOR (mechlorethamine hydrochloride) gel in an original application for the treatment of mycosis fungoides, a type of cutan…