Breast Cancer

• FDA approval · 2014-06-30
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approves a supplemental application for Faslodex (fulvestrant) submitted by AstraZeneca Pharmaceuticals LP. The action updates the drug’…

• FDA approval · 2014-06-13
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)

  FDA approved a supplemental application for a kit used to prepare Lymphoseek (tilmanocept) with technetium-99m, submitted by Cardinal Health…

• 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…

• FDA approval · 2014-05-06
  FDA Approved: ANASTROZOLE — Supplemental Application (Natco Pharma Limited)

  FDA approved Natco Pharma Limited's supplemental application for anastrozole (generic) under the ANDA.

• FDA approval · 2014-05-02
  FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ARIMIDEX (anastrozole) filed by ANI Pharmaceuticals, Inc.

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• FDA approval · 2014-05-02
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for EXEMESTANE by Mylan Pharmaceuticals, updating the product labeling.

• FDA approval · 2014-01-15
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for FEMARA (letrozole) from Novartis, indicating approval of a supplement to the original NDA.

• FDA approval · 2013-12-04
  FDA Approved: KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a kit used to prepare Technetium-99m sulfur colloid for nuclear medicine imaging.

• FDA approval · 2013-10-18
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tykerb (lapatinib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2013-10-08
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for FASLODEX (fulvestrant) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2013-09-30
  FDA Approved: PERJETA — Supplemental Application (Genentech, Inc.)

  FDA approves a supplemental application for Perjeta (pertuzumab) by Genentech, expanding its approved use.

• FDA approval · 2013-09-16
  FDA Approved: CAPECITABINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Capecitabine as an original application for Teva Pharmaceuticals USA, confirming a generic version of the chemotherapy agent.

• FDA approval · 2013-08-29
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for KADCYLA (ado-trastuzumab emtansine) submitted by Genentech, resulting in an updated label/in…

• FDA approval · 2013-08-19
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2013-07-11
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for FEMARA (letrozole) submitted by Novartis Pharmaceuticals Corporation. The action updates the…

• FDA approval · 2013-06-21
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TYKERB (lapatinib) submitted by Novartis Pharmaceuticals Corporation.

• 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 · 2013-05-01
  FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ARIMIDEX (anastrozole) filed by ANI Pharmaceuticals, Inc. The action relates to an updated/expan…

• FDA approval · 2013-04-08
  FDA Approved: ANASTROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Anastrozole from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-03-13
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Original Application (Cardinal Health 414, LLC)

  FDA approved the kit for the preparation of Lymphoseek (technetium-99m tilmanocept), enabling production of the radiopharmaceutical used for…

• FDA approval · 2013-02-22
  FDA Approved: KADCYLA — Original Application (Genentech, Inc.)

  The FDA approved KADCYLA (ado-trastuzumab emtansine) from Genentech as an original application for the treatment of HER2-positive metastatic…

• FDA approval · 2013-02-15
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Exemestane submitted by Mylan Pharmaceuticals Inc. The action involves approval of changes t…

• FDA approval · 2013-02-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

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

• 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 · 2013-01-09
  FDA Approved: VINORELBINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Vinorelbine submitted by Sagent Pharmaceuticals, making a generic version of the cancer drug ava…