Breast Cancer

• FDA approval · 2008-05-22
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2008-01-18
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2007-11-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA PHARMACEUTICALS, INC., signaling an expanded/updated …

• FDA approval · 2007-10-16
  FDA Approved: IXEMPRA — Original Application (R-Pharm US Operating, LLC)

  FDA approved IXEMPRA (ixabepilone) through an original NDA for metastatic or locally advanced breast cancer.

• FDA approval · 2007-08-20
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TYKERB (lapatinib) from Novartis Pharmaceuticals Corporation to update its labeling.

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• FDA approval · 2007-07-17
  FDA Approved: EVISTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for EVISTA (raloxifene hydrochloride) from Eli Lilly and Company.

• FDA approval · 2007-04-27
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2007-04-26
  FDA Approved: FLUOROURACIL — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare’s original application for Fluorouracil as a generic injectable chemotherapy agent for multiple cancers.

• FDA approval · 2007-04-11
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Femara (letrozole) from Novartis Pharmaceuticals Corporation, updating the existing NDA.

• FDA approval · 2007-03-13
  FDA Approved: TYKERB — Original Application (Novartis Pharmaceuticals Corporation)

  FDA's Original Application page documents the original FDA approval of TYKERB (lapatinib) for HER2-overexpressing breast cancer.

• FDA approval · 2007-02-02
  FDA Approved: TAMOXIFEN CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for tamoxifen citrate (generic) from Mylan Pharmaceuticals, supporting continued approval for th…

• FDA approval · 2007-01-25
  FDA Approved: TAMOXIFEN CITRATE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Tamoxifen Citrate submitted by Actavis Pharma, Inc.

• FDA approval · 2006-12-01
  FDA Approved: TAMOXIFEN CITRATE — Supplemental Application (Mayne Pharma Commercial LLC)

  The FDA approved a supplemental application for tamoxifen citrate from Mayne Pharma Commercial LLC.