Non-hodgkin Lymphoma

• FDA approval · 2013-02-26
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Mozobil (plerixafor) submitted by Sanofi-Aventis U.S. LLC.

• 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 · 2012-06-26
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for TREANDA (bendamustine hydrochloride) submitted by Cephalon, LLC.

• FDA approval · 2011-11-18
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for ZEVALIN (ibritumomab tiuxetan) submitted by Acrotech Biopharma Inc.

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• 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 · 2011-01-07
  FDA Approved: FOLOTYN — Supplemental Application (Acrotech Biopharma Inc)

  FDA approved a supplemental application for FOLOTYN (pralatrexate) from Acrotech Biopharma Inc.

• FDA approval · 2010-12-16
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

  The FDA approved a supplemental application for ZEVALIN (ibritumomab tiuxetan) filed by Acrotech Biopharma Inc.

• FDA approval · 2010-02-26
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for TREANDA (bendamustine hydrochloride) from Cephalon, LLC, enabling revisions to its labeling …

• FDA approval · 2009-10-16
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) from Genentech.

• FDA approval · 2009-09-03
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

  The FDA approved a supplemental application for ZEVALIN (ibritumomab tiuxetan) submitted by Acrotech Biopharma Inc. This action updates ZEVA…

• FDA approval · 2008-12-15
  FDA Approved: MOZOBIL — Original Application (Sanofi-Aventis U.S. LLC)

  FDA approved Mozobil (plerixafor) under an Original Application (NDA022311) to mobilize hematopoietic stem cells in combination with G-CSF f…

• FDA approval · 2008-03-25
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

  FDA has approved a supplemental application for Zevalin (ibritumomab tiuxetan) filed by Acrotech Biopharma Inc.

• FDA approval · 2007-10-15
  FDA Approved: FLUDARABINE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for Fludarabine phosphate (generic fludarabine) from Fresenius Kabi USA, LLC. The approval covers use …

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

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