Hormone Receptor-positive Breast Cancer

• FDA approval · 2025-10-30
  FDA Approved: EVEROLIMUS — Original Application (Novugen Pharma (USA) LLC.)

  FDA approved a generic version of Everolimus from Novugen Pharma (USA) LLC under an Original Application (ANDA).

• FDA approval · 2025-09-17
  FDA Approved: FULVESTRANT — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Fulvestrant filed by Hikma Pharmaceuticals USA Inc. This action formalizes an updated regula…

• FDA approval · 2025-02-11
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application to offer a Kisqali-Femara co-pack, combining ribociclib with letrozole. The co-pack is intended …

• FDA approval · 2024-04-30
  FDA Approved: EVEROLIMUS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Everolimus submitted by Hikma Pharmaceuticals USA Inc. This action updates approved labeling…

• FDA approval · 2021-12-10
  FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to approve a co-packaged formulation of KISQALI (ribociclib) with FEMARA (letrozole), enabling their…

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• 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 · 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…