Acute Lymphoblastic Leukemia

• FDA approval · 2017-11-06
  FDA Approved: CLOFARABINE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' generic clofarabine (Clofarabine) under ANDA205375.

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

  FDA approves a generic original application for Clofarabine (Clofarabine) by Mylan Institutional LLC.

• FDA approval · 2017-11-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for doxorubicin hydrochloride from BluePoint Laboratories, adding a new approved generic version of …

• 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 · 2017-08-17
  FDA Approved: BESPONSA — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved BESPONSA (inotuzumab ozogamicin) under an original application for adults with relapsed or refractory CD22-positive B-cell prec…

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• 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 · 2017-05-09
  FDA Approved: CLOFARABINE — Original Application (Zydus Lifesciences Limited)

  FDA approves a generic version of Clofarabine under Original Application ANDA204029 from Zydus Lifesciences Limited, for relapsed or refract…

• FDA approval · 2017-03-07
  FDA Approved: METHOTREXATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for METHOTREXATE SODIUM from Fresenius Kabi USA, LLC.

• FDA approval · 2016-12-20
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  FDA approved a supplemental application for TREXALL (methotrexate) from Teva Women's Health, Inc.

• 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 · 2016-09-27
  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.

• FDA approval · 2016-08-17
  FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for imatinib mesylate, a generic version of the cancer drug, to update its approval status.

• FDA approval · 2016-08-04
  FDA Approved: IMATINIB MESYLATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approval of Teva's Imatinib Mesylate Original Application under ANDA204285 for a generic Imatinib product.

• FDA approval · 2016-06-16
  FDA Approved: LEVOLEUCOVORIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s levoleucovorin as an Original Application generic; levoleucovorin is used in cancer regimens w…

• EMA approval · 2016-04-29
  New treatment for rare white blood cell cancer

  The EMA announces a new treatment for a rare white blood cell cancer, representing a targeted option for this rare indication.

• FDA approval · 2015-12-03
  FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)

  FDA approved the original application for Imatinib Mesylate from BluePoint Laboratories (ANDA078340), authorizing a generic version of the c…

• FDA approval · 2015-12-01
  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 · 2014-12-03
  FDA Approved: BLINCYTO — Original Application (Amgen, Inc)

  The FDA approved BLINCYTO (blinatumomab) from Amgen as an original application. It is a novel bispecific T-cell engager indicated for relaps…

• FDA approval · 2014-11-05
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for doxorubicin hydrochloride (Fresenius Kabi USA, LLC) under anANDA to support its generic product.

• FDA approval · 2014-10-25
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica, Inc. to market a generic cyclophosphamide product.

• FDA approval · 2014-07-30
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA granted approval of a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2014-07-24
  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 · 2014-04-28
  FDA Approved: MERCAPTOPURINE — Original Application (Nova Laboratories, Ltd)

  FDA approved mercaptopurine (Purixan) under its original NDA (NDA205919) for the treatment of acute lymphoblastic leukemia, representing Nov…