Chronic Myeloid Leukemia

• FDA approval · 2024-01-05
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application from Mylan Pharmaceuticals for imatinib mesylate, enabling a generic version to be marketed under AN…

• 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 · 2023-09-26
  FDA Approved: BOSULIF — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves BOSULIF (bosutinib) as the original application for Philadelphia chromosome-positive chronic myeloid leukemia in adults with re…

• FDA approval · 2023-09-26
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Bosulif (bosutinib) from Pfizer Laboratories Div Pfizer Inc. This action updates the drug's …

• FDA approval · 2023-09-22
  FDA Approved: DASATINIB — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for dasatinib by Apotex Corp. The approval allows the generic product to be marketed.

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• FDA approval · 2023-08-16
  FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the…

• FDA approval · 2023-04-20
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for BOSULIF (bosutinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2023-02-08
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Dasatinib submitted by Prasco Laboratories. The action approves an additional submission under N…

• FDA approval · 2023-01-31
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Imatinib Mesylate from BluePoint Laboratories under an ANDA, confirming approval of a generic pr…

• FDA approval · 2022-06-21
  FDA Approved: IMATINIB MESYLATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved an original application for imatinib mesylate (Upsher-Smith Laboratories) as a generic product. The approval supports its use f…

• 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 · 2022-01-21
  FDA Approved: BUSULFAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Busulfan by Amneal Pharmaceuticals LLC, updating the approval for this generic product.

• FDA approval · 2022-01-03
  FDA Approved: DASATINIB — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for dasatinib (DASATINIB) filed by Apotex Corp. The action confirms regulatory approval related to t…

• FDA approval · 2021-11-23
  FDA Approved: DASATINIB — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s generic dasatinib (DASATINIB) under an Original Application (ANDA) for use in Philadelphia chromosome–positive l…

• FDA approval · 2021-10-29
  FDA Approved: SCEMBLIX — Original Application (Novartis Pharmaceuticals Corporation)

  The FDA approved SCEMBLIX (asciminib) from Novartis as an original approval for chronic myeloid leukemia. It represents a first-in-class tar…

• 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 · 2021-06-29
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories, enabling continued or expanded marketing under a…

• FDA approval · 2021-05-14
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Bosulif (bosutinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2021-03-25
  FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for imatinib from Dr. Reddy's Laboratories, supporting an update to the drug's labeling under the AN…

• 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 · 2020-08-10
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis, approving changes to the product labeling based o…

• FDA approval · 2020-07-23
  FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

  FDA approved imatinib mesylate as an original-application generic drug for BluePoint Laboratories.

• FDA approval · 2020-07-10
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc., approving changes t…

• FDA approval · 2020-06-17
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Iclusig (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2020-01-09
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for imatinib mesylate from Teva Pharmaceuticals USA, Inc., under ANDA204285.