Ovarian Cancer

• FDA approval · 2017-01-19
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC.

• FDA approval · 2016-12-19
  FDA Approved: RUBRACA — Original Application (pharmaand GmbH)

  FDA approved the original application for Rubraca (rucaparib) from pharmaand GmbH.

• FDA approval · 2016-11-17
  FDA Approved: GEMCITABINE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for gemcitabine under ANDA 079183. This represents approval of a supplemental submissi…

• FDA approval · 2016-08-23
  FDA Approved: PACLITAXEL PACLITAXEL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original application for a generic paclitaxel product, manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac…

• 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…

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• FDA approval · 2015-11-17
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's supplemental application for Topotecan hydrochloride, enabling a generic version of the cancer drug to be m…

• FDA approval · 2015-10-09
  FDA Approved: DOXORUBICIN HYDROCHLORIDE LIPOSOME — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter's supplemental NDA for doxorubicin hydrochloride liposome.

• FDA approval · 2015-09-28
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Topotecan Hydrochloride by Actavis Pharma, Inc., granting continued regulatory approval for this…

• FDA approval · 2015-06-02
  FDA Approved: HYCAMTIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for HYCAMTIN (topotecan hydrochloride) from Novartis Pharmaceuticals Corporation.

• EMA approval · 2014-10-24
  Lynparza recommended for approval in ovarian cancer

  The EMA recommends approving Lynparza (olaparib) for ovarian cancer, indicating potential new treatment option pending final authorization.

• FDA approval · 2014-05-15
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Docetaxel (Sanofi-Aventis U.S. LLC), indicating an approved modification to its labeling and…

• EMA approval · 2014-03-21
  EMA recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic

  EMA recommends approval of a new treatment for platinum-resistant ovarian cancer, coordinated with a companion diagnostic to identify eligib…

• FDA approval · 2014-02-28
  FDA Approved: HYCAMTIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Hycamtin (topotecan hydrochloride) from Novartis Pharmaceuticals Corporation. The action likely …

• FDA approval · 2013-06-26
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's original application for a generic topotecan hydrochloride product.

• 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 · 2013-02-04
  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 · 2012-11-13
  FDA Approved: CISPLATIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for cisplatin filed by Fresenius Kabi USA, LLC. This action confirms the continued approval of cispl…

• FDA approval · 2012-03-15
  FDA Approved: CISPLATIN — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for cisplatin from Teva Parenteral Medicines, Inc., marking an approved change to the drug's regulat…

• FDA approval · 2011-10-07
  FDA Approved: HYCAMTIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for HYCAMTIN (topotecan) submitted by Sandoz Inc.

• FDA approval · 2011-08-26
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC, resulting in an updated regulatory status for the …

• FDA approval · 2011-07-25
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Original Application (Teyro Labs Private Limited)

  The FDA approved an original ANDA for gemcitabine hydrochloride from Teyro Labs Private Limited, enabling its generic use.

• FDA approval · 2011-07-14
  FDA Approved: MELPHALAN HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Melphalan Hydrochloride from Mylan Institutional LLC, authorizing the generic drug's continued m…

• FDA approval · 2011-06-29
  FDA Approved: DOCETAXEL — Original Application (Baxter Healthcare Corporation)

  FDA approved the original application for docetaxel by Baxter Healthcare Corporation, marking its initial U.S. approval as a cancer therapy.…

• FDA approval · 2010-12-02
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for Topotecan Hydrochloride from Actavis Pharma, Inc. as a generic cancer therapy.

• FDA approval · 2010-03-26
  FDA Approved: HYCAMTIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for HYCAMTIN (topotecan hydrochloride) submitted by Novartis Pharmaceuticals Corporation.