Breast Cancer

• FDA approval · 2019-09-05
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for docetaxel (docetaxel anhydrous) by Mylan Institutional LLC under ANDA 210072.

• FDA approval · 2019-09-05
  FDA Approved: ANASTROZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Anastrozole from Zydus Lifesciences Limited. The document concerns the approval of a generic ver…

• FDA approval · 2019-08-23
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic raloxifene hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2019-08-23
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  FDA approved a supplemental application for raloxifene hydrochloride submitted by ScieGen Pharmaceuticals Inc.

• FDA approval · 2019-08-22
  FDA Approved: FULVESTRANT — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  The FDA approved Glenmark Pharmaceuticals' generic fulvestrant for the treatment of hormone receptor-positive metastatic breast cancer in po…

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• FDA approval · 2019-07-26
  FDA Approved: ELLENCE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Ellence (epirubicin hydrochloride) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2019-07-12
  FDA Approved: ISOSULFAN BLUE — Original Application (Somerset Therapeutics, LLC)

  FDA approved an original ANDA for Isosulfan Blue from Somerset Therapeutics, LLC, a surgical dye used for sentinel lymph node mapping in bre…

• FDA approval · 2019-06-28
  FDA Approved: OGIVRI — Supplemental Application (Biocon Biologics Inc.)

  FDA approved a supplemental Biologics License Application for OGIVRI (trastuzumab-dkst) from Biocon Biologics Inc., updating its labeling/pe…

• FDA approval · 2019-06-21
  FDA Approved: CAPECITABINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' original application for Capecitabine, granting a generic version of the cancer drug Capecit…

• FDA approval · 2019-06-13
  FDA Approved: KANJINTI — Original Application (Amgen, Inc)

  FDA approves KANJINTI (trastuzumab-anns) from Amgen as a biosimilar to trastuzumab. It is approved for HER2-overexpressing breast cancer and…

• FDA approval · 2019-05-24
  FDA Approved: PIQRAY — Original Application (Novartis Pharmaceuticals Corporation)

  The FDA approved PIQRAY (alpelisib) as the original application by Novartis for use in adults with HR-positive, HER2-negative, PIK3CA-mutate…

• FDA approval · 2019-05-20
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for FASLODEX (fulvestrant) from AstraZeneca Pharmaceuticals LP, updating its labeling and/or indicat…

• FDA approval · 2019-05-20
  FDA Approved: FULVESTRANT — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fulvestrant through an Original Application (NDA210326) for Fresenius Kabi USA, LLC.

• FDA approval · 2019-05-19
  FDA Approved: LETROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Letrozole submitted by Teva Pharmaceuticals USA, Inc., updating the label and/or indications…

• FDA approval · 2019-05-14
  FDA Approved: FULVESTRANT — Original Application (Sandoz Inc)

  The FDA approved Sandoz's original ANDA for fulvestrant, providing a generic version of the breast cancer therapy Fulvestrant.

• FDA approval · 2019-05-03
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for KADCYLA (ado-trastuzumab emtansine) submitted by Genentech, Inc., regarding an amendment to the …

• FDA approval · 2019-04-17
  FDA Approved: OGIVRI — Supplemental Application (Biocon Biologics Inc.)

  The FDA approved Biocon Biologics' supplemental application for OGIVRI (trastuzumab-dkst), a trastuzumab biosimilar.

• FDA approval · 2019-04-08
  FDA Approved: SOLTAMOX — Supplemental Application (Mayne Pharma)

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

• FDA approval · 2019-04-01
  FDA Approved: DOCETAXEL — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Docetaxel from Dr. Reddy's Laboratories Inc., authorizing the generic product under the approved…

• FDA approval · 2019-03-13
  FDA Approved: DOCETAXEL ANHYDROUS — Supplemental Application (Meitheal Pharmaceuticals Inc)

  The FDA approved a supplemental application from Meitheal Pharmaceuticals to market docetaxel anhydrous as a generic chemotherapy drug.

• FDA approval · 2019-03-11
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Faslodex (fulvestrant) submitted by AstraZeneca Pharmaceuticals LP, authorizing changes to i…

• FDA approval · 2019-03-11
  FDA Approved: TRAZIMERA — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved TRAZIMERA (trastuzumab-qyyP) from Pfizer as an original biologics license application. It is a biosimilar to trastuzumab indica…

• FDA approval · 2019-03-04
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie Inc.

• FDA approval · 2019-03-04
  FDA Approved: FULVESTRANT — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's generic Fulvestrant under Original Application (ANDA).

• FDA approval · 2019-02-28
  FDA Approved: HERCEPTIN HYLECTA — Original Application (Genentech, Inc.)

  FDA approved HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) under an original application by Genentech for treating HER2-positive br…