Breast Cancer

• FDA approval · 2015-05-29
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for KADCYLA (ado-trastuzumab emtansine) filed by Genentech, expanding its regulatory status.

• FDA approval · 2015-05-08
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Leuprolide acetate submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-04-22
  FDA Approved: SOLTAMOX — Supplemental Application (Mayne Pharma)

  The FDA approved a supplemental application for Soltamox (tamoxifen citrate) filed by Mayne Pharma.

• FDA approval · 2015-02-13
  FDA Approved: LETROZOLE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic letrozole, confirming regulatory authorization for this product. Thi…

• FDA approval · 2015-02-13
  FDA Approved: LETROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for letrozole, a generic aromatase inhibitor used to treat breast cancer in postmenopausal wome…

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• FDA approval · 2015-02-03
  FDA Approved: IBRANCE — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved IBRANCE (palbociclib) through its original NDA. It addresses advanced or metastatic breast cancer.

• FDA approval · 2015-01-16
  FDA Approved: ANASTROZOLE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for ANASTROZOLE (anastrozole), authorizing the generic to be marketed for approved…

• FDA approval · 2015-01-05
  FDA Approved: XELODA — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for XELODA (capecitabine) from H2-Pharma, LLC.

• FDA approval · 2014-12-22
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2014-12-05
  FDA Approved: CAPECITABINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2014-11-05
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for doxorubicin hydrochloride (Fresenius Kabi USA, LLC) under anANDA to support its generic product.

• FDA approval · 2014-11-05
  FDA Approved: DOCETAXEL — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves the original (ANDA) application for docetaxel generic produced by Dr. Reddy's Laboratories.

• FDA approval · 2014-10-25
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica, Inc. to market a generic cyclophosphamide product.

• FDA approval · 2014-10-14
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)

  The FDA approved a supplemental application to authorize Cardinal Health 414, LLC to prepare the Lymphoseek radiopharmaceutical kit (technet…

• FDA approval · 2014-10-10
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

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

• FDA approval · 2014-10-07
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  The FDA approved a supplemental application for ZOLADEX (goserelin) filed by TerSera Therapeutics LLC. This action typically updates labelin…

• FDA approval · 2014-09-24
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original generic application for raloxifene hydrochloride, enabling a generic version of the osteoporosis …

• FDA approval · 2014-08-25
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Faslodex (fulvestrant) from AstraZeneca Pharmaceuticals, resulting in an updated label follo…

• FDA approval · 2014-08-01
  FDA Approved: HALAVEN — Supplemental Application (BSP Pharmaceuticals SpA)

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

• FDA approval · 2014-07-22
  FDA Approved: XELODA — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for XELODA (capecitabine) from H2-Pharma, LLC. This notice confirms regulatory approval of a cha…

• FDA approval · 2014-07-19
  FDA Approved: LETROZOLE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic letrozole, confirming regulatory approval of the generic aromatase i…

• FDA approval · 2014-07-18
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approves a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval updates th…

• FDA approval · 2014-07-11
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2014-07-10
  FDA Approved: DOCETAXEL — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for Docetaxel.

• FDA approval · 2014-06-30
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

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