Breast Cancer

• FDA approval · 2016-10-26
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Faslodex (fulvestrant) submitted by AstraZeneca Pharmaceuticals LP. This notice confirms the…

• FDA approval · 2016-10-12
  FDA Approved: ZORTRESS — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ZORTRESS (everolimus) submitted by Novartis Pharmaceuticals Corporation. The action likely a…

• EMA approval · 2016-09-16
  New treatment for breast cancer

  The EMA announces a new treatment for breast cancer, indicating a regulatory approval or favorable assessment for a breast cancer therapy.

• 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 · 2016-07-26
  FDA Approved: IXEMPRA — Supplemental Application (R-Pharm US Operating, LLC)

  FDA approved a supplemental application for IXEMPRA (ixabepilone) from R-Pharm US Operating, LLC, resulting in updated labeling.

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• FDA approval · 2016-07-25
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for KADCYLA (ado-trastuzumab emtansine) submitted by Genentech, Inc. The submission status is listed…

• FDA approval · 2016-07-25
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Exemestane from Mylan Pharmaceuticals Inc., enabling a generic aromatase inhibitor to be mar…

• FDA approval · 2016-07-12
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Faslodex (fulvestrant) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2016-05-19
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for FASLODEX (fulvestrant) from AstraZeneca Pharmaceuticals LP. This action updates the product …

• FDA approval · 2016-04-28
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Kadcyla (ado-trastuzumab emtansine) from Genentech.

• FDA approval · 2016-04-04
  FDA Approved: CAPECITABINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for CAPECITABINE submitted by BluePoint Laboratories. The action concerns the generic capecitabi…

• FDA approval · 2016-03-02
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for FASLODEX (fulvestrant) from AstraZeneca Pharmaceuticals LP. This action indicates regulatory…

• FDA approval · 2016-03-01
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Faslodex (fulvestrant) via a supplemental application from AstraZeneca Pharmaceuticals LP. The action represents a supplemental…

• FDA approval · 2016-02-29
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA Pharmaceuticals.

• FDA approval · 2016-02-18
  FDA Approved: CAPECITABINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for capecitabine filed by Teva Pharmaceuticals USA, Inc. (ANDA 091649).

• FDA approval · 2016-02-02
  FDA Approved: ISOSULFAN BLUE — Original Application (Eugia US LLC)

  FDA approved the original application for Isosulfan Blue by Eugia US LLC, authorizing its use as a lymphatic mapping dye for sentinel lymph …

• FDA approval · 2016-01-26
  FDA Approved: GEMCITABINE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' supplemental application for gemcitabine hydrochloride (gemcitabine), enabling continued producti…

• FDA approval · 2016-01-11
  FDA Approved: EVISTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Evista to expand its labeling. The update adds a use for reducing breast cancer risk in postmeno…

• FDA approval · 2015-11-18
  FDA Approved: HALAVEN — Supplemental Application (BSP Pharmaceuticals SpA)

  FDA approved a supplemental application for HALAVEN (eribulin mesylate) from BSP Pharmaceuticals SpA.

• FDA approval · 2015-09-21
  FDA Approved: METHYLTESTOSTERONE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC for methyltestosterone as an Original Application (generic) to bring a generic version o…

• FDA approval · 2015-08-28
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for raloxifene hydrochloride as a generic medication for postmenopausal ost…

• FDA approval · 2015-08-18
  FDA Approved: FLUOROURACIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fluorouracil submitted by Mylan Pharmaceuticals, resulting in an updated regulatory status for t…

• FDA approval · 2015-08-03
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)

  FDA supplemental approval for the KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) by Cardinal Health 414, LLC, enablin…

• FDA approval · 2015-07-23
  FDA Approved: ANASTROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for anastrozole, authorizing the approval of a generic version of the cancer drug.

• FDA approval · 2015-06-08
  FDA Approved: MEGESTROL ACETATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' supplemental application for Megestrol Acetate (generic megestrol acetate) under ANDA 203139.