Chronic Myeloid Leukemia

• FDA approval · 2019-10-09
  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.

• FDA approval · 2019-08-14
  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, signaling an update to the …

• FDA approval · 2019-04-18
  FDA Approved: BUSULFAN — Original Application (Armas Pharmaceuticals Inc.)

  FDA approved a generic Busulfan from Armas Pharmaceuticals Inc. under ANDA210931, enabling a generic formulation.

• FDA approval · 2019-01-17
  FDA Approved: IMATINIB MESYLATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' imatinib mesylate as an original application for a generic version of the cancer drug, for the same indica…

• FDA approval · 2019-01-17
  FDA Approved: IMATINIB MESYLATE — Original Application (Chartwell RX, LLC)

  FDA approves an original ANDA for imatinib mesylate, granting Chartwell RX, LLC a generic version (ANDA 208429).

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• FDA approval · 2018-12-21
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

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

• 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 · 2018-09-28
  FDA Approved: BUSULFEX — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Busultex (busulfan) filed by Otsuka America Pharmaceutical, Inc. The action updates the labeling…

• FDA approval · 2018-08-13
  FDA Approved: IMATINIB — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved the original application for imatinib from Dr. Reddy's Laboratories Inc, enabling the generic product to be marketed in the Uni…

• FDA approval · 2018-05-29
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2017-12-22
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2017-12-19
  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 expands the regulat…

• FDA approval · 2017-12-18
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2017-11-20
  FDA Approved: BUSULFAN — Original Application (Mylan Institutional LLC)

  FDA approved a generic busulfan under an Original Application with Mylan Institutional LLC.

• 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 · 2017-09-29
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental NDA for GLEEVEC (imatinib mesylate) filed by Novartis Pharmaceuticals Corporation, resulting in changes to the p…

• FDA approval · 2017-08-10
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

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

• 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 · 2017-04-13
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Bosulif (bosutinib) from Pfizer, updating the product labeling in connection with the supple…

• FDA approval · 2016-11-28
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2016-11-17
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Bosulif (bosutinib) submitted by Pfizer Laboratories Div Pfizer Inc. This action represents …

• 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 · 2016-09-27
  FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2016-09-07
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, resulting in changes to t…

• FDA approval · 2016-08-25
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis Pharmaceuticals Corporation.