Breast Cancer

• FDA approval · 2017-12-01
  FDA Approved: OGIVRI — Original Application (Biocon Biologics Inc.)

  The FDA approved OGIVRI (trastuzumab-dkst) from Biocon Biologics as a biosimilar to trastuzumab through Biocon's Original Application. It is…

• FDA approval · 2017-11-14
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Faslodex (fulvestrant) submitted by AstraZeneca Pharmaceuticals LP. This action updates the …

• FDA approval · 2017-11-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for doxorubicin hydrochloride from BluePoint Laboratories, adding a new approved generic version of …

• FDA approval · 2017-09-28
  FDA Approved: VERZENIO — Original Application (Eli Lilly and Company)

  The FDA approved the original application for VERZENIO (abemaciclib) from Eli Lilly and Company.

• FDA approval · 2017-08-25
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

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• FDA approval · 2017-08-09
  FDA Approved: DOCETAXEL — Original Application (Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

  FDA approved a generic version of docetaxel under an original ANDA from Jiangsu Hengrui Pharmaceuticals Co., Ltd., enabling market authoriza…

• FDA approval · 2017-08-03
  FDA Approved: GEMCITABINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's gemcitabine injectable drug as an original application, providing a generic version of the anticancer agent…

• FDA approval · 2017-07-26
  FDA Approved: EXEMESTANE — Original Application (Upsher-Smith Laboratories, Inc.)

  FDA approved Upsher-Smith's generic exemestane through an original ANDA, expanding access to this aromatase inhibitor. The product is used i…

• FDA approval · 2017-07-17
  FDA Approved: NERLYNX — Original Application (Puma Biotechnology, Inc.)

  FDA approved Nerlynx (neratinib) as the original application for extended adjuvant therapy in adult patients with early-stage HER2-positive …

• FDA approval · 2017-07-13
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Femara (letrozole) filed by Novartis, updating the product labeling.

• FDA approval · 2017-05-19
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)

  FDA approved a supplemental application for leuprolide acetate from Meitheal Pharmaceuticals Inc, related to the existing approval for this …

• FDA approval · 2017-05-04
  FDA Approved: KISQALI FEMARA CO-PACK — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved the Kisqali Femara co-pack, combining ribociclib with letrozole for the treatment of hormone receptor-positive, HER2-negative b…

• FDA approval · 2017-04-27
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for HERCEPTIN (trastuzumab) submitted by Genentech, Inc. The action pertains to a supplemental appro…

• FDA approval · 2017-04-06
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2017-03-31
  FDA Approved: IBRANCE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for IBRANCE (palbociclib) submitted by Pfizer, resulting in an update to the drug's labeling.

• FDA approval · 2017-03-27
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for HERCEPTIN (trastuzumab) submitted by Genentech, Inc.

• FDA approval · 2017-03-13
  FDA Approved: KISQALI — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved Kisqali (ribociclib) in its original application (NDA 209092) from Novartis Pharmaceuticals Corporation for a breast cancer ind…

• FDA approval · 2017-01-13
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA PHARMACEUTICALS, INC., resulting in label…

• FDA approval · 2017-01-06
  FDA Approved: FLUOROURACIL — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Fluorouracil from Fresenius Kabi USA, LLC.

• FDA approval · 2016-12-14
  FDA Approved: FLUOROURACIL — Supplemental Application (Eugia US LLC)

  The FDA has approved a supplemental application for Fluorouracil from Eugia US LLC, formalizing an update to the product under the ANDA path…

• FDA approval · 2016-12-12
  FDA Approved: CAPECITABINE 150MG — Original Application (Armas Pharmaceuticals Inc.)

  FDA approves Armas Pharmaceuticals Inc.'s Capecitabine 150 mg as an Original Application generic drug (ANDA 207456).

• FDA approval · 2016-11-30
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)

  The FDA approved a supplemental application for a kit to prepare Lymphoseek (technetium-99m tilmanocept) for injection, enabling on-site pre…

• FDA approval · 2016-11-17
  FDA Approved: GEMCITABINE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for gemcitabine under ANDA 079183. This represents approval of a supplemental submissi…

• FDA approval · 2016-10-31
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2016-10-28
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for FEMARA (letrozole) from Novartis Pharmaceuticals Corporation. The approval indicates an upda…