Castration-sensitive Prostate Cancer

• FDA approval · 2023-12-19
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for ERLEADA (apalutamide) filed by Janssen Products, LP. The approval updates the drug's labelin…

• FDA approval · 2023-03-23
  FDA Approved: ABIRATERONE ACETATE — Original Application (Florida Pharmaceutical Products, LLC)

  FDA approved an abbreviated new drug application for a generic version of abiraterone acetate from Florida Pharmaceutical Products, LLC, for…

• FDA approval · 2023-02-17
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP. The approval expands the drug's label f…

• FDA approval · 2022-11-08
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for Erleada (apalutamide) submitted by Janssen Products, LP.

• FDA approval · 2022-04-26
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for ERLEADA (apalutamide) filed by Janssen Products, LP.

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• FDA approval · 2020-07-10
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP, resulting in an expanded or updated…

• FDA approval · 2018-02-14
  FDA Approved: ERLEADA — Original Application (Janssen Products, LP)

  FDA approved ERLEADA (apalutamide) from Janssen Products, LP as the original NDA (NDA210951). It is approved for certain forms of prostate c…

• FDA approval · 2015-03-20
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ZYTIGA (abiraterone acetate) from Janssen Biotech, Inc.