Non-hodgkin Lymphoma

• 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 · 2018-12-11
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

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

• FDA approval · 2018-10-16
  FDA Approved: CARMUSTINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the original ANDA for Carmustine (BiCNU) submitted by Amneal Pharmaceuticals LLC.

• 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 · 2018-09-11
  FDA Approved: CARMUSTINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Carmustine as an original ANDA for Zydus Pharmaceuticals USA Inc., authorizing a generic Carmustine formulation. The drug is us…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2017-12-01
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Mozobil (plerixafor) filed by Sanofi-Aventis U.S. 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 · 2017-06-22
  FDA Approved: RITUXAN HYCELA — Original Application (Genentech, Inc.)

  FDA approved RITUXAN HYCELA (rituximab and hyaluronidase) under an Original Application by Genentech. The subcutaneous formulation provides …

• 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 · 2017-02-06
  FDA Approved: BENDEKA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Bendeka (bendamustine hydrochloride) submitted by Teva Pharmaceuticals USA, Inc., reflecting an …

• 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 · 2016-06-23
  FDA Approved: BENDEKA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Bendeka (bendamustine hydrochloride) submitted by Teva Pharmaceuticals USA, Inc., indicating reg…

• FDA approval · 2016-05-12
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2016-04-28
  FDA Approved: CARMUSTINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Carmustine submitted by Heritage Pharmaceuticals Inc. (doing business as Avet Pharmaceutical…

• FDA approval · 2015-08-04
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a supplemental application for MOZOBIL (plerixafor) from Sanofi-Aventis U.S. LLC. The action updates the product's labeling and…

• FDA approval · 2015-07-08
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

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

• FDA approval · 2015-06-01
  FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for mitoxantrone hydrochloride, submitted by Fresenius Kabi USA, LLC.

• 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 · 2014-03-27
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

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

• FDA approval · 2013-08-30
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

  The FDA approved a supplemental application for ZEVALIN (ibritumomab tiuxetan) submitted by Acrotech Biopharma 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 · 2013-06-04
  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.

• EMA approval · 2013-03-14
  EMA Refused: Istodax (romidepsin) — Celgene Europe Ltd.

  The EMA refused approval for Istodax (romidepsin) by Celgene Europe Ltd. for lymphoma/non-Hodgkin indications.