Acute Lymphoblastic Leukemia

• 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 · 2020-06-17
  FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONCASPAR (pegaspargase) submitted by Servier Pharmaceuticals LLC.

• FDA approval · 2020-04-07
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)

  FDA approved a supplemental application for Mercaptopurine (Purixan) submitted by Nova Laboratories, Ltd.

• FDA approval · 2020-03-20
  FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for BLINCYTO (blinatumomab), expanding the drug's regulatory authorization beyond the orig…

• FDA approval · 2020-01-30
  FDA Approved: METHOTREXATE — Original Application (Chartwell RX, LLC)

  FDA approvedChartwell RX, LLC's methotrexate product under an Original Application, making a new generic version of methotrexate available. …

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• FDA approval · 2019-09-05
  FDA Approved: ASPARLAS — Supplemental Application (Servier Pharmaceuticals LLC)

  FDA issued a supplemental approval for ASPARLAS (calaspargase pegol) from Servier Pharmaceuticals LLC.

• FDA approval · 2019-08-22
  FDA Approved: LEVOLEUCOVORIN — Original Application (Meitheal Pharmaceuticals Inc)

  FDA approved Meitheal Pharmaceuticals' levoleucovorin calcium as an original application (ANDA) for a generic product.

• FDA approval · 2019-04-18
  FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for BLINCYTO (blinatumomab) submitted by Amgen, signaling an update to labeling and/or indicatio…

• 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 · 2019-01-18
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of 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).

• FDA approval · 2019-01-03
  FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONCASPAR (pegaspargase) submitted by Servier Pharmaceuticals LLC.

• 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 · 2018-12-20
  FDA Approved: ASPARLAS — Original Application (Servier Pharmaceuticals LLC)

  The FDA approved ASPARLAS (calaspargase pegol) from Servier Pharmaceuticals as a treatment for acute lymphoblastic leukemia.

• 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 · 2018-09-27
  FDA Approved: DAUNORUBICIN HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for daunorubicin hydrochloride (Hikma Pharmaceuticals USA Inc.).

• 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 · 2018-07-27
  FDA Approved: LEUCOVORIN CALCIUM — Original Application (Fresenius Kabi USA, LLC)

  FDA approved a generic Leucovorin Calcium under ANDA 207226 for Fresenius Kabi USA, LLC.

• FDA approval · 2018-07-17
  FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approves the original application for CYTARABINE (cytarabine) from Meitheal Pharmaceuticals Inc., making a generic cytarabine product av…

• 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 · 2018-05-23
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)

  The FDA approved a supplemental application for mercaptopurine from Florida Pharmaceutical Products, LLC.

• FDA approval · 2018-03-15
  FDA Approved: METHOTREXATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Methotrexate submitted by Hospira, Inc.

• FDA approval · 2017-11-09
  FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved the original abbreviated new drug application for Cytarabine from Meitheal Pharmaceuticals, enabling the generic injectable…

• FDA approval · 2017-11-06
  FDA Approved: CLOFARABINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves a generic version of CLOFARABINE (Amneal) under an Original Application for the treatment of acute lymphoblastic leukemia.