Peripheral T-cell Lymphoma

• FDA approval · 2025-03-10
  FDA Approved: PRALATREXATE — Original Application (Dr.Reddy's Laboratories Inc.,)

  FDA approved an Original Application for pralatrexate by Dr. Reddy's Laboratories Inc., enabling a generic version of the anti-cancer drug.

• 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 · 2020-05-14
  FDA Approved: FOLOTYN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for FOLOTYN (pralatrexate) submitted by Acrotech Biopharma Inc. The approval relates to its use in t…

• FDA approval · 2020-01-08
  FDA Approved: BELEODAQ — Supplemental Application (Acrotech Biopharma Inc)

  The FDA approved a supplemental application for BELEODAQ (belinostat) from Acrotech Biopharma Inc.

• 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…

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• FDA approval · 2017-04-12
  FDA Approved: BELEODAQ — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for Beleodaq (belinostat) submitted by Acrotech Biopharma Inc.

• 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 · 2015-04-23
  FDA Approved: BELEODAQ — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for Beleodaq (belinostat) submitted by Acrotech Biopharma Inc. This action denotes a supplemental re…

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

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

• FDA approval · 2014-07-03
  FDA Approved: BELEODAQ — Original Application (Acrotech Biopharma Inc)

  FDA approved Beleodaq (belinostat) from Acrotech Biopharma for relapsed or refractory peripheral T-cell lymphoma, marking an original drug a…

• FDA approval · 2012-05-30
  FDA Approved: FOLOTYN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approves a supplemental application for FOLOTYN (pralatrexate) submitted by Acrotech Biopharma Inc., granting an additional regulatory a…

• FDA approval · 2012-02-15
  FDA Approved: FOLOTYN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for Folotyn (pralatrexate) submitted by Acrotech Biopharma Inc.

• FDA approval · 2011-04-12
  FDA Approved: ISTODAX — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2011-01-07
  FDA Approved: FOLOTYN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for FOLOTYN (pralatrexate) from Acrotech Biopharma Inc.

• FDA approval · 2010-04-26
  FDA Approved: FOLOTYN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for FOLOTYN (pralatrexate) from Acrotech Biopharma Inc, updating the product labeling.

• FDA approval · 2009-09-24
  FDA Approved: FOLOTYN — Original Application (Acrotech Biopharma Inc)

  FDA approved Folotyn (pralatrexate) as an initial approval for relapsed or refractory peripheral T-cell lymphoma.