Breast Cancer

• FDA approval · 2012-09-26
  FDA Approved: VINORELBINE — Original Application (Sagent Pharmaceuticals)

  FDA approved the original ANDA for vinorelbine (VINORELBINE) from Sagent Pharmaceuticals.

• FDA approval · 2012-07-17
  FDA Approved: FLUOROURACIL — Original Application (Eugia US LLC)

  FDA-approved the original ANDA for fluorouracil from Eugia US LLC, granting a generic version of fluorouracil for cancer chemotherapy.

• FDA approval · 2012-07-17
  FDA Approved: FLUOROURACIL — Original Application (Eugia US LLC)

  FDA approved the original ANDA for Fluorouracil by Eugia US LLC, enabling the marketing of a generic fluorouracil chemotherapy product.

• FDA approval · 2012-06-08
  FDA Approved: PERJETA — Original Application (Genentech, Inc.)

  The FDA approved PERJETA (pertuzumab) from Genentech as the original application for the treatment of HER2-positive metastatic breast cancer…

• FDA approval · 2012-05-15
  FDA Approved: LETROZOLE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare’s generic letrozole product.

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• FDA approval · 2012-03-02
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tykerb (lapatinib) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2012-02-17
  FDA Approved: HALAVEN — Supplemental Application (BSP Pharmaceuticals SpA)

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

• FDA approval · 2011-12-23
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for FEMARA (letrozole) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2011-11-22
  FDA Approved: ANASTROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Anastrozole submitted by Teva Pharmaceuticals USA, Inc. under ANDA078058, marking an additional …

• FDA approval · 2011-11-14
  FDA Approved: ANASTROZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Anastrozole submitted by Zydus Lifesciences Limited.

• FDA approval · 2011-10-18
  FDA Approved: IXEMPRA — Supplemental Application (R-Pharm US Operating, LLC)

  The FDA approved a supplemental application for IXEMPRA (ixabepilone) submitted by R-Pharm US Operating, LLC, indicating an updated labeling…

• FDA approval · 2011-09-26
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Faslodex (fulvestrant) submitted by AstraZeneca, updating labeling and/or indications.

• FDA approval · 2011-08-12
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• 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 · 2011-06-29
  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 · 2011-06-14
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) by AbbVie, expanding its approved indications and labeling.

• FDA approval · 2011-06-03
  FDA Approved: LETROZOLE — Original Application (Natco Pharma Limited)

  The FDA approved Natco Pharma Limited's original application for a generic letrozole product.

• FDA approval · 2011-06-03
  FDA Approved: LETROZOLE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' generic letrozole as an original application; letrozole is used to treat hormone receptor-positive br…

• FDA approval · 2011-06-03
  FDA Approved: LETROZOLE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's generic letrozole as an original ANDA application.

• FDA approval · 2011-06-03
  FDA Approved: LETROZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original ANDA for letrozole (generic), enabling its marketing as a generic aromatase inhibitor. The approval covers the …

• FDA approval · 2011-05-17
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2011-04-26
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Leuprolide Acetate from Sun Pharmaceutical Industries, resulting in changes to the product's…

• FDA approval · 2011-04-18
  FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Arimidex (anastrozole) submitted by ANI Pharmaceuticals, Inc. This represents regulatory app…

• FDA approval · 2011-04-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) filed by Uronova Pharmaceuticals. This action approves the supplem…

• FDA approval · 2011-03-28
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc. for Leuprolide acetate (ANDA 074728).