Breast Cancer

• FDA approval · 2019-02-22
  FDA Approved: EXEMESTANE — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for Exemestane submitted by Cipla USA Inc.

• FDA approval · 2019-02-22
  FDA Approved: EXEMESTANE — Supplemental Application (Upsher-Smith Laboratories, Inc.)

  The FDA approved a supplemental application for Exemestane (Upsher-Smith Laboratories) under an ANDA, affecting a generic aromatase inhibito…

• FDA approval · 2019-02-19
  FDA Approved: IBRANCE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for IBRANCE (palbociclib) from Pfizer, indicating an update to the drug's regulatory status (such as…

• FDA approval · 2019-02-13
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to co-pack Kisqali (ribociclib) with Femara (letrozole), enabling a fixed-dose co-pack for postmenop…

• FDA approval · 2019-01-18
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of a generic formulation …

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• FDA approval · 2019-01-11
  FDA Approved: LETROZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for a generic version of letrozole.

• FDA approval · 2018-12-14
  FDA Approved: HERZUMA — Original Application (Cephalon, Inc.)

  FDA approved Herzuma (trastuzumab) through an original Biologics License Application, establishing it as a biosimilar to trastuzumab for ind…

• FDA approval · 2018-12-13
  FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for ARIMIDEX (anastrozole) under NDA 020541.

• FDA approval · 2018-12-06
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tykerb (lapatinib) from Novartis Pharmaceuticals Corporation, approving an additional indication…

• FDA approval · 2018-12-04
  FDA Approved: TOREMIFENE CITRATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings' generic toremifene citrate (ANDA 208813) for the treatment of breast cancer.

• FDA approval · 2018-11-29
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Herceptin (trastuzumab) from Genentech, updating the label to reflect a new or expanded indicati…

• FDA approval · 2018-11-14
  FDA Approved: LETROZOLE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for Letrozole tablets as a generic version.

• FDA approval · 2018-11-09
  FDA Approved: ANASTROZOLE — Original Application (Avet Pharmaceuticals Inc)

  FDA approves the original application for Anastrozole tablets (generic) manufactured by Avet Pharmaceuticals Inc. This marks another generic…

• FDA approval · 2018-10-16
  FDA Approved: TALZENNA — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved TALZENNA (talazoparib) as a single-agent treatment for adults with deleterious or suspected deleterious germline BRCA-mutated, …

• FDA approval · 2018-10-03
  FDA Approved: EXEMESTANE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original application for Exemestane as a generic drug, manufactured by Zydus Pharmaceuticals USA Inc., for the treatment of…

• FDA approval · 2018-09-20
  FDA Approved: PERJETA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for PERJETA (pertuzumab) filed by Genentech, Inc.

• FDA approval · 2018-07-20
  FDA Approved: GEMCITABINE — Original Application (Sagent Pharmaceuticals)

  FDA approves Sagent Pharmaceuticals' original ANDA for gemcitabine, a generic injectable chemotherapy used to treat several cancers.

• FDA approval · 2018-07-02
  FDA Approved: CAPECITABINE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s generic capecitabine under an Abbreviated New Drug Application (ANDA).

• FDA approval · 2018-07-02
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  FDA approved an original application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC. The generic is an i…

• FDA approval · 2018-05-18
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for exemestane from Mylan Pharmaceuticals, enabling the marketing of a generic exemestane produc…

• FDA approval · 2018-04-30
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  The FDA approved Mylan Institutional LLC's original application for a generic docetaxel anhydrous product (ANDA208859).

• FDA approval · 2018-04-27
  FDA Approved: EXEMESTANE — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s generic Exemestane as an original ANDA approval (ANDA 210323).

• FDA approval · 2018-04-23
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to introduce a Kisqali (ribociclib) and Femara (letrozole) co-packaged product, enabling combined us…

• FDA approval · 2018-04-17
  FDA Approved: CAPECITABINE — Original Application (Aurobindo Pharma Limited)

  FDA approved Capecitabine from Aurobindo Pharma Limited under an Original Application, making a generic version available.

• FDA approval · 2018-04-05
  FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for FEMARA (letrozole) submitted by Novartis Pharmaceuticals Corporation.