Breast Cancer

• FDA approval · 2011-03-25
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approval of a supplemental application for Exemestane by Mylan Pharmaceuticals Inc. is noted. Exemestane is a drug used in the treatment…

• FDA approval · 2011-03-17
  FDA Approved: ANASTROZOLE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Anastrozole from Accord Healthcare Inc., enabling a generic version of the breast cancer therapy…

• FDA approval · 2011-01-25
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.

• FDA approval · 2010-11-15
  FDA Approved: HALAVEN — Original Application (BSP Pharmaceuticals SpA)

  FDA approved the original application for HALAVEN (eribulin mesylate) by BSP Pharmaceuticals SpA for metastatic breast cancer in patients wh…

• FDA approval · 2010-10-29
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Herceptin (trastuzumab) submitted by Genentech.

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• FDA approval · 2010-10-20
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for HERCEPTIN (trastuzumab) submitted by Genentech.

• FDA approval · 2010-09-09
  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 drug's l…

• FDA approval · 2010-06-28
  FDA Approved: ANASTROZOLE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original application for generic anastrozole.

• FDA approval · 2010-06-28
  FDA Approved: ANASTROZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original application for a generic anastrozole product, expanding access to this aromatase inhibitor for breast cancer t…

• FDA approval · 2010-06-28
  FDA Approved: ANASTROZOLE — Original Application (Natco Pharma Limited)

  This FDA page confirms Natco Pharma Limited's original approval of a generic anastrozole product for the treatment of hormone receptor-posit…

• FDA approval · 2010-06-28
  FDA Approved: ANASTROZOLE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for generic anastrozole from Zydus Lifesciences Limited, used to treat hormone receptor-positive breas…

• FDA approval · 2010-06-25
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for FEMARA (letrozole) from Novartis Pharmaceuticals Corporation, updating the labeling for breast c…

• FDA approval · 2010-05-26
  FDA Approved: VINORELBINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Vinorelbine from Actavis Pharma, Inc., indicating an update to its labeling/indications.

• FDA approval · 2010-05-12
  FDA Approved: IXEMPRA — Supplemental Application (R-Pharm US Operating, LLC)

  The FDA approved a supplemental application for IXEMPRA (ixabepilone) by R-Pharm US Operating, LLC.

• FDA approval · 2010-04-30
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for FEMARA (letrozole) filed by Novartis Pharmaceuticals Corporation.

• FDA approval · 2010-03-05
  FDA Approved: FLUOROURACIL — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved the original application for a generic fluorouracil product manufactured by Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2010-01-29
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tykerb (lapatinib) by Novartis Pharmaceuticals Corporation. The action updates the product label…

• FDA approval · 2009-07-07
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2009-04-30
  FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals, Inc.'s supplemental application for ARIMIDEX (anastrozole). This action typically updates labeling, in…

• FDA approval · 2009-04-08
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Herceptin (trastuzumab) submitted by Genentech, Inc. This action updates the product's label…

• FDA approval · 2009-03-13
  FDA Approved: IXEMPRA — Supplemental Application (R-Pharm US Operating, LLC)

  FDA has approved a supplemental application for IXEMPRA (ixabepilone) submitted by R-Pharm US Operating, LLC. This action approves an amendm…

• FDA approval · 2008-12-24
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Exemestane submitted by Mylan Pharmaceuticals Inc., indicating approval of a generic Exemest…

• FDA approval · 2008-12-10
  FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

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

• FDA approval · 2008-08-07
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for FEMARA (letrozole) submitted by Novartis Pharmaceuticals Corporation to update the drug's label.

• FDA approval · 2008-07-07
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

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