Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

• FDA approval · 2025-11-19
  FDA Approved: NILOTINIB — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' generic nilotinib under an Original Application (ANDA). It is indicated for chronic myeloid leukemia …

• FDA approval · 2025-11-19
  FDA Approved: NILOTINIB — Original Application (AvKARE)

  FDA approved AvKARE's nilotinib original application, authorizing a generic version of nilotinib for leukemia indications.

• FDA approval · 2025-11-19
  FDA Approved: NILOTINIB — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic nilotinib product. The generic is intended to treat certain Philadel…

• FDA approval · 2025-11-06
  FDA Approved: DASATINIB — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic version of dasatinib (DASATINIB) from Alembic Pharmaceuticals Limited under an Original Application. The approval mak…

• FDA approval · 2025-08-27
  FDA Approved: DASATINIB — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva Pharmaceuticals' original application to market a generic dasatinib product.

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• FDA approval · 2025-08-25
  FDA Approved: DASATINIB — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic dasatinib (original ANDA) for the treatment of Philadelphia chromosome-positive chronic myeloid …

• FDA approval · 2025-03-03
  FDA Approved: DASATINIB — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved an original application for dasatinib from Zydus Pharmaceuticals USA Inc., enabling a generic version of the cancer drug. D…

• FDA approval · 2024-07-31
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories, resulting in an approved change to its labeling and/…

• FDA approval · 2024-03-19
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) submitted by Takeda Pharmaceuticals America, Inc. The appr…

• FDA approval · 2024-02-06
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TASIGNA (nilotinib) submitted by Novartis, resulting in changes to the labeling under the supple…

• FDA approval · 2023-12-05
  FDA Approved: PHYRAGO — Original Application (Cycle Pharmaceuticals Ltd)

  The FDA approved PHYRAGO (dasatinib) from Cycle Pharmaceuticals Ltd under an original application. Dasatinib is indicated for Philadelphia c…

• FDA approval · 2022-02-18
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. The approval updates aspe…

• FDA approval · 2021-09-23
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TASIGNA (nilotinib) from Novartis.

• FDA approval · 2020-12-08
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. This action pertains to a…

• FDA approval · 2018-11-15
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories.

• FDA approval · 2017-11-09
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for dasatinib filed by Prasco Laboratories, resulting in updated labeling for this drug.

• FDA approval · 2017-06-21
  FDA Approved: IMATINIB MESYLATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's original application for imatinib mesylate tablets, a generic version of Gleevec, for the same indications as the refer…

• FDA approval · 2016-09-27
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tasigna (nilotinib) from Novartis Pharmaceuticals Corporation, resulting in updated labeling…

• FDA approval · 2016-06-10
  FDA Approved: DASATINIB — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original generic application for dasatinib (DASATINIB). The approval provides a generic version of dasatinib for…

• FDA approval · 2015-10-15
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. The approval pertains to …

• FDA approval · 2015-04-23
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) submitted by Takeda Pharmaceuticals America, Inc., under NDA 2…

• FDA approval · 2015-01-26
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for dasatinib by Prasco Laboratories, enabling the marketing of a generic version. The drug is indic…

• FDA approval · 2014-09-25
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2013-08-14
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) from Novartis Pharmaceuticals Corporation. The approval updates the labeling…

• FDA approval · 2013-05-22
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) to update the product labeling.