Breast Cancer

• FDA approval · 2020-05-19
  FDA Approved: MEGESTROL ACETATE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's supplemental application for megestrol acetate.

• FDA approval · 2020-05-13
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2020-04-27
  FDA Approved: CAPECITABINE — Original Application (Lifestar Pharma LLC)

  FDA approves the original application for a generic capecitabine tablet by Lifestar Pharma LLC. This marks the availability of a generic ver…

• FDA approval · 2020-04-17
  FDA Approved: TUKYSA — Original Application (SEAGEN INC.)

  FDA approves TUKYSA (tucatinib) in an original application for adults with HER2-positive metastatic breast cancer, including those with brai…

• FDA approval · 2020-04-13
  FDA Approved: EXEMESTANE — Original Application (Florida Pharmaceutical Products, LLC)

  FDA approved Florida Pharmaceutical Products, LLC's original application for Exemestane, a generic version of exemestane (Aromasin). The pro…

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• FDA approval · 2020-03-18
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2020-02-25
  FDA Approved: NERLYNX — Supplemental Application (Puma Biotechnology, Inc.)

  FDA approved a supplemental application for Nerlynx (neratinib) filed by Puma Biotechnology. This action approves a supplemental indication …

• FDA approval · 2020-02-07
  FDA Approved: FULVESTRANT — Original Application (Sagent Pharmaceuticals)

  FDA approved an original application for a generic fulvestrant product from Sagent Pharmaceuticals for breast cancer treatment.

• FDA approval · 2020-01-24
  FDA Approved: TRAZIMERA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Pfizer's supplemental Biologics License Application for TRAZIMERA (trastuzumab-qyyP), a biosimilar to trastuzumab.

• FDA approval · 2020-01-21
  FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for KISQALI (ribociclib) submitted by Novartis Pharmaceuticals Corporation. The action updates the p…

• FDA approval · 2020-01-21
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application to co-pack Kisqali (ribociclib) with Femara (letrozole) in a single package, enabling a combined…

• FDA approval · 2020-01-16
  FDA Approved: PERJETA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Perjeta (pertuzumab) by Genentech, resulting in changes to the drug's labeling.

• FDA approval · 2019-12-27
  FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP. The approval updates the product labeli…

• FDA approval · 2019-11-21
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2019-11-21
  FDA Approved: FULVESTRANT — Original Application (Meitheal Pharmaceuticals Inc)

  FDA approved the original application for a generic Fulvestrant product from Meitheal Pharmaceuticals Inc.

• FDA approval · 2019-11-01
  FDA Approved: IBRANCE — Original Application (U.S. Pharmaceuticals)

  FDA approved IBRANCE (palbociclib) in its original application for HR-positive, HER2-negative advanced or metastatic breast cancer in postme…

• FDA approval · 2019-10-25
  FDA Approved: KANJINTI — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for KANJINTI (trastuzumab-anns) submitted by Amgen, Inc. The action represents a regulatory approval…

• FDA approval · 2019-10-10
  FDA Approved: CAPECITABINE 150MG — Supplemental Application (Armas Pharmaceuticals Inc.)

  The FDA approved a supplemental application to add a 150 mg strength of capecitabine, manufactured by Armas Pharmaceuticals Inc., expanding …

• FDA approval · 2019-10-09
  FDA Approved: CAPECITABINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Capecitabine (CAPECITABINE) from Ascend Laboratories, LLC under ANDA207652.

• FDA approval · 2019-10-03
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for gemcitabine hydrochloride from Gland Pharma Limited. This approval enables the marketing of …

• FDA approval · 2019-10-01
  FDA Approved: NERLYNX — Supplemental Application (Puma Biotechnology, Inc.)

  The FDA approved a supplemental application for Nerlynx (neratinib) submitted by Puma Biotechnology, Inc. This action updates the drug’s lab…

• FDA approval · 2019-09-24
  FDA Approved: TALZENNA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for TALZENNA (talazoparib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2019-09-09
  FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for KISQALI (ribociclib) from Novartis, updating the label to include an additional breast cance…

• FDA approval · 2019-09-09
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to authorize a Kisqali-Femara co-pack containing ribociclib and letrozole.

• FDA approval · 2019-09-09
  FDA Approved: IBRANCE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for IBRANCE (palbociclib) from Pfizer Laboratories Div Pfizer Inc, authorizing changes to its labeli…