Breast Cancer

• FDA approval · 2021-02-11
  FDA Approved: EVEROLIMUS — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's original application (ANDA) for Everolimus, a generic version of the mTOR inhibitor. The approval enables a g…

• FDA approval · 2021-01-19
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Faslodex (fulvestrant) from AstraZeneca Pharmaceuticals LP, updating the product label.

• FDA approval · 2021-01-14
  FDA Approved: DOCETAXEL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for generic docetaxel. Docetaxel is a chemotherapy agent used to treat mu…

• FDA approval · 2020-12-16
  FDA Approved: MARGENZA — Original Application (TerSera Therapeutics LLC)

  FDA approved MARGENZA (margetuximab-cmkb) from TerSera Therapeutics as an original application for adults with metastatic HER2-positive brea…

• FDA approval · 2020-12-11
  FDA Approved: GEMCITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic gemcitabine hydrochloride under an original ANDA.

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• FDA approval · 2020-11-17
  FDA Approved: FULVESTRANT — Original Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare's Original Application for a generic fulvestrant (Fulvestrant) for the treatment of metastatic breast cancer.

• FDA approval · 2020-10-28
  FDA Approved: ANASTROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for ANASTROZOLE from Teva Pharmaceuticals USA, Inc. This action approves the supplemental submission…

• FDA approval · 2020-10-20
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Zoledronic acid from Hikma Pharmaceuticals USA Inc., indicating regulatory approval for the spon…

• FDA approval · 2020-10-06
  FDA Approved: GEMCITABINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for gemcitabine from Fresenius Kabi USA, approving a generic gemcitabine product under ANDA 090799. …

• FDA approval · 2020-09-29
  FDA Approved: LAPATINIB — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' original ANDA for Lapatinib, a generic version used in treating breast cancer.

• FDA approval · 2020-09-27
  FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2020-09-10
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC.

• FDA approval · 2020-09-01
  FDA Approved: PIQRAY — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for PIQRAY (alpelisib) from Novartis Pharmaceuticals Corporation. This action approves the reque…

• FDA approval · 2020-08-20
  FDA Approved: VINORELBINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for VINORELBINE (vinorelbine) from Sagent Pharmaceuticals.

• FDA approval · 2020-08-20
  FDA Approved: LETROZOLE — Supplemental Application (Natco Pharma Limited)

  FDA issued a supplemental approval for Natco Pharma Limited's generic letrozole under an ANDA. Letrozole is used to treat hormone receptor-p…

• FDA approval · 2020-08-18
  FDA Approved: TOREMIFENE CITRATE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved a generic version of toremifene citrate through an original ANDA submitted by Novadoz Pharmaceuticals LLC.

• FDA approval · 2020-08-14
  FDA Approved: TAMOXIFEN CITRATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Original Application for Tamoxifen Citrate, a generic version of tamoxifen.

• FDA approval · 2020-08-07
  FDA Approved: LETROZOLE — Supplemental Application (Natco Pharma Limited)

  FDA approves Natco Pharma Limited's supplemental application for letrozole (generic). This action updates the labeling/approval status of th…

• FDA approval · 2020-08-07
  FDA Approved: FULVESTRANT — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' generic Fulvestrant through an Original Application (ANDA).

• FDA approval · 2020-07-29
  FDA Approved: NERLYNX — Supplemental Application (Puma Biotechnology, Inc.)

  The FDA approved a supplemental application for NERLYNX (neratinib) filed by Puma Biotechnology, Inc., resulting in updated labeling/additio…

• FDA approval · 2020-07-27
  FDA Approved: VINORELBINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for vinorelbine by Sagent Pharmaceuticals, reflecting updated authorization for the drug.

• FDA approval · 2020-07-24
  FDA Approved: ANASTROZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for a generic version of anastrozole from Aurobindo Pharma Limited.

• FDA approval · 2020-07-06
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for a Kisqali-Femara co-pack, combining ribociclib and letrozole in a single co-pack managed by Nova…

• FDA approval · 2020-06-29
  FDA Approved: PHESGO — Original Application (Genentech, Inc.)

  FDA approved PHESGO (PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF) from Genentech under an Original Application; a fixed-dose subcutaneou…

• FDA approval · 2020-06-08
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic Everolimus under an Original Application, enabling the sale of a generic version of th…