Breast Cancer

• FDA approval · 2023-05-31
  FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP, resulting in changes to the product…

• FDA approval · 2023-03-07
  FDA Approved: GEMCITABINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic gemcitabine under an Original Application (ANDA). This marks the approval of a generic…

• FDA approval · 2023-03-03
  FDA Approved: VERZENIO — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for VERZENIO (abemaciclib) submitted by Eli Lilly and Company.

• FDA approval · 2023-01-27
  FDA Approved: ORSERDU — Original Application (Stemline Therapeutics, Inc.)

  FDA approved ORSERDU (elacestrant) for ER-positive, HER2-negative advanced or metastatic breast cancer following aromatase inhibitor therapy…

• FDA approval · 2023-01-19
  FDA Approved: TUKYSA — Supplemental Application (SEAGEN INC.)

  FDA approved a supplemental application for TUKYSA (tucatinib) from Seagen, resulting in an updated label/indication for the drug.

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• FDA approval · 2023-01-11
  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.

• FDA approval · 2023-01-06
  FDA Approved: TRODELVY — Supplemental Application (Gilead Sciences, Inc.)

  FDA approves a supplemental application for TRODELVY (sacituzumab govitecan) from Gilead Sciences, expanding the drug's label.

• FDA approval · 2022-12-22
  FDA Approved: FULVESTRANT — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' original application for a generic Fulvestrant product. Fulvestrant is used to treat hormone receptor-…

• FDA approval · 2022-11-22
  FDA Approved: DOCIVYX — Original Application (Avyxa Pharma, LLC)

  FDA approves DOCIVYX (docetaxel) under an original NDA submitted by Avyxa Pharma, LLC.

• FDA approval · 2022-10-20
  FDA Approved: PACLITAXEL — Original Application (BluePoint Laboratories)

  FDA approves paclitaxel as a generic product under an original application from BluePoint Laboratories.

• FDA approval · 2022-10-18
  FDA Approved: FLUOROURACIL — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for fluorouracil submitted by Taro Pharmaceuticals U.S.A., Inc., approving changes to the product’s …

• FDA approval · 2022-10-11
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for raloxifene hydrochloride from Amneal Pharmaceuticals LLC, authorizing a regulatory change under …

• FDA approval · 2022-10-03
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to offer a Kisqali (ribociclib) and Femara (letrozole) co-pack, enabling combination therapy in brea…

• FDA approval · 2022-09-16
  FDA Approved: ISOSULFAN BLUE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved Isosulfan Blue from Novadoz Pharmaceuticals LLC under an Original Application/ANDA, establishing a generic option for uses such…

• FDA approval · 2022-09-14
  FDA Approved: FLUOROURACIL — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for fluorouracil submitted by BluePoint Laboratories, indicating approval of an ANDA supplement. Thi…

• FDA approval · 2022-08-11
  FDA Approved: ENHERTU — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approved a supplemental application for ENHERTU (fam-trastuzumab deruxtecan-nxki) filed by Daiichi Sankyo, Inc.

• FDA approval · 2022-08-05
  FDA Approved: ENHERTU — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approved a supplemental application for ENHERTU (fam-trastuzumab deruxtecan-nxki) from Daiichi Sankyo Inc. to update labeling and/or add…

• FDA approval · 2022-07-27
  FDA Approved: PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND — Original Application (American Regent, Inc.)

  FDA approved paclitaxel protein-bound particles albumin-bound (paclitaxel) from American Regent, Inc. under an Original Application (NDA2118…

• FDA approval · 2022-07-08
  FDA Approved: EXEMESTANE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application to bring a generic Exemestane product to market. The sponsor is Zydus Pharmaceuticals USA Inc.

• FDA approval · 2022-06-15
  FDA Approved: EXEMESTANE — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for exemestane (Cipla USA Inc.). This action approves a supplemental change to the product's lab…

• FDA approval · 2022-06-15
  FDA Approved: EXEMESTANE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved a supplemental application for Exemestane from Breckenridge Pharmaceutical, Inc. The approval pertains to the generic product u…

• FDA approval · 2022-05-24
  FDA Approved: EXEMESTANE — Supplemental Application (Florida Pharmaceutical Products, LLC)

  FDA approved a supplemental application for exemestane submitted by Florida Pharmaceutical Products, LLC.

• FDA approval · 2022-05-20
  FDA Approved: EXEMESTANE — Original Application (Aurobindo Pharma Limited)

  The FDA approved the original ANDA for Exemestane from Aurobindo Pharma Limited, establishing a generic aromatase inhibitor. It relates to t…

• FDA approval · 2022-05-04
  FDA Approved: PIQRAY — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for PIQRAY (alpelisib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2022-05-04
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to authorize Kisqali Femara Co-Pack, a co-packaged product combining ribociclib and letrozole for th…