T-cell Acute Lymphoblastic Leukemia

• FDA approval · 2025-07-25
  FDA Approved: NELARABINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Nelarabine by Zydus Lifesciences Limited under ANDA 215037. This action updates the regulatory s…

• FDA approval · 2025-03-11
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Arranon (nelarabine) filed by Sandoz Inc., resulting in changes to the product's labeling.

• FDA approval · 2024-09-13
  FDA Approved: NELARABINE — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved an original-application abbreviated new drug application for nelarabine from Novadoz Pharmaceuticals LLC, enabling the mark…

• FDA approval · 2024-09-05
  FDA Approved: NELARABINE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved the original application for nelarabine as a generic drug, with XGen Pharmaceuticals DJB, Inc. listed as the manufacturer.

• FDA approval · 2024-08-01
  FDA Approved: NELARABINE — Original Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's Nelarabine Original Application (ANDA 218554), granting approval for a generic Nelarabine…

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• FDA approval · 2024-01-03
  FDA Approved: NELARABINE — Original Application (Sagent Pharmaceuticals)

  FDA approved Nelarabine under an Original Application from Sagent Pharmaceuticals. It is indicated for T-cell acute lymphoblastic leukemia a…

• FDA approval · 2023-03-03
  FDA Approved: NELARABINE — Original Application (Shorla Oncology Inc.)

  The FDA approved a generic Nelarabine (Shorla Oncology Inc.) under an Original Abbreviated New Drug Application, confirming bioequivalence t…

• FDA approval · 2023-01-10
  FDA Approved: NELARABINE — Original Application (Meitheal Pharmaceuticals Inc)

  FDA approves Meitheal Pharmaceuticals' nelarabine original application (ANDA216038) for a generic formulation of nelarabine.

• FDA approval · 2022-12-22
  FDA Approved: NELARABINE — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approves Dr. Reddy's Nelarabine as a generic under an Original Application for use in treating T-cell acute lymphoblastic leukemia and T…

• FDA approval · 2021-11-17
  FDA Approved: NELARABINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Nelarabine from Zydus Lifesciences Limited, enabling generic access for treating T-cell acute lymp…

• FDA approval · 2019-08-02
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ARRANON (nelarabine) submitted by Sandoz Inc.

• FDA approval · 2018-11-29
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for ARRANON (nelarabine) submitted by Sandoz Inc.

• FDA approval · 2018-07-03
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz Inc.'s supplemental application for ARRANON (nelarabine), resulting in a labeling update for the product.

• FDA approval · 2015-06-04
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ARRANON (nelarabine) from Sandoz Inc. Nelarabine is indicated for T-cell acute lymphoblastic leu…

• FDA approval · 2012-02-06
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for ARRANON (nelarabine) submitted by Sandoz Inc.

• FDA approval · 2009-12-15
  FDA Approved: ARRANON — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ARRANON (nelarabine) from Sandoz Inc. This action concerns the supplemental NDA submitted by San…