Castration-resistant Prostate Cancer

• FDA approval · 2021-12-01
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Dr. Reddys Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' supplemental application for abiraterone acetate, enabling a generic version of the cancer drug.

• FDA approval · 2021-11-22
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Abiraterone acetate from Apotex Corp. (generic).

• FDA approval · 2021-11-12
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (NORTHSTAR RX LLC)

  FDA approved a supplemental application for Abiraterone acetate (generic) submitted by NorthStar RX LLC under ANDA 209227.

• FDA approval · 2021-08-23
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for ZYTIGA (abiraterone acetate) submitted by Janssen Biotech, Inc., though the specifics of the…

• FDA approval · 2021-07-14
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

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

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• FDA approval · 2021-07-02
  FDA Approved: ABIRATERONE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Abiraterone acetate (generic Abiraterone) from Hikma Pharmaceuticals USA, Inc., expanding access…

• FDA approval · 2021-04-05
  FDA Approved: ABIRATERONE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for ABIRATERONE ACETATE (BluePoint Laboratories) under ANDA 210686.

• FDA approval · 2021-04-05
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Florida Pharmaceutical Products, LLC.)

  FDA approved a supplemental application for Abiraterone acetate from Florida Pharmaceutical Products, LLC., representing a supplemental appr…

• FDA approval · 2021-04-05
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (NORTHSTAR RX LLC)

  FDA approved a supplemental application for abiraterone acetate (generic version). The product is manufactured by NorthStar RX LLC.

• FDA approval · 2020-12-18
  FDA Approved: JEVTANA — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Jevtana (cabazitaxel) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2020-12-14
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Abiraterone Acetate from Mylan Pharmaceuticals Inc., supporting the availability of a generi…

• FDA approval · 2020-11-20
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's supplemental application for Abiraterone acetate, a generic version of the cancer drug.

• FDA approval · 2020-10-23
  FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for XTANDI (enzalutamide) from Astellas Pharma US to modify/expand its label for prostate cancer ind…

• FDA approval · 2020-10-02
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ZYTIGA (abiraterone acetate) from Janssen Biotech, Inc., resulting in an updated labeling/indica…

• FDA approval · 2020-09-17
  FDA Approved: YONSA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for YONSA (abiraterone acetate) submitted by Sun Pharmaceutical Industries, Inc., updating the l…

• FDA approval · 2020-08-04
  FDA Approved: XTANDI — Original Application (Astellas Pharma US, Inc.)

  FDA approves XTANDI (enzalutamide) under the original application NDA213674 for metastatic castration-resistant prostate cancer.

• FDA approval · 2020-05-18
  FDA Approved: ABIRATERONE ACETATE — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories Inc's original application for Abiraterone acetate, enabling a generic version of the cancer drug for …

• FDA approval · 2020-03-05
  FDA Approved: JEVTANA — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for JEVTANA (cabazitaxel) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2019-12-16
  FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for XTANDI (enzalutamide) from Astellas Pharma US, resulting in an updated label.

• FDA approval · 2019-12-10
  FDA Approved: XOFIGO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for XOFIGO (Radium Ra-223 dichloride) submitted by Bayer HealthCare Pharmaceuticals Inc., markin…

• FDA approval · 2019-10-16
  FDA Approved: ABIRATERONE ACETATE — Original Application (NORTHSTAR RX LLC)

  FDA approved the original ANDA for abiraterone acetate submitted by NorthStar RX LLC.

• FDA approval · 2019-09-27
  FDA Approved: ABIRATERONE ACETATE — Original Application (Florida Pharmaceutical Products, LLC.)

  FDA approved a generic version of abiraterone acetate under an original ANDA from Florida Pharmaceutical Products, LLC for metastatic castra…

• FDA approval · 2019-07-10
  FDA Approved: ABIRATERONE — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' original application for ABIRATERONE acetate as a generic version for prostate cancer (metastatic castr…

• FDA approval · 2019-06-03
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2019-02-25
  FDA Approved: ABIRATERONE ACETATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic abiraterone acetate, manufactured by Rising Pharma Holdings, expanding access for treatm…