Acute Lymphoblastic Leukemia

• FDA approval · 2014-04-22
  FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)

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

• FDA approval · 2014-01-30
  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 · 2013-06-17
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for cyclophosphamide from Civica, Inc. under ANDA 040745.

• FDA approval · 2013-05-17
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-05-14
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for mercaptopurine from Mylan Pharmaceuticals Inc., authorizing a generic version under an appro…

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• FDA approval · 2013-02-05
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA's supplemental application for methotrexate, enabling the marketing of a generic methotrexate product…

• FDA approval · 2013-02-04
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Original Application (BluePoint Laboratories)

  FDA approved a generic doxorubicin hydrochloride product under Original Application for BluePoint Laboratories (ANDA 203263). This marks app…

• FDA approval · 2013-01-25
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis, reflecting changes to the product labeling.

• FDA approval · 2012-12-20
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. The action typically upda…

• FDA approval · 2012-12-14
  FDA Approved: ICLUSIG — Original Application (Takeda Pharmaceuticals America, Inc.)

  This FDA page documents the original approval of ICLUSIG (ponatinib hydrochloride) by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2012-08-01
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Mercaptopurine from Hikma Pharmaceuticals USA Inc., supporting the generic product under AND…

• FDA approval · 2011-05-27
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)

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

• FDA approval · 2011-04-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for METHOTREXATE from Hikma Pharmaceuticals USA Inc., granting a supplemental approval for the g…

• FDA approval · 2011-03-23
  FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)

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

• FDA approval · 2008-12-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis Pharmaceuticals Corporation, resulting in regulatory a…

• FDA approval · 2007-09-13
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2007-04-30
  FDA Approved: METHOTREXATE — Original Application (Accord Healthcare, Inc.)

  The FDA approved Accord Healthcare's original application for Methotrexate (generic).

• FDA approval · 2006-10-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2006-07-24
  FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)

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