Castration-resistant Prostate Cancer

• FDA approval · 2014-05-13
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2014-04-17
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2014-04-01
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ZYTIGA (abiraterone acetate) from Janssen Biotech, Inc., resulting in a label modification/expan…

• FDA approval · 2014-02-07
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2013-09-11
  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.

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• FDA approval · 2013-06-17
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2013-05-15
  FDA Approved: XOFIGO — Original Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved XOFIGO (radium-223 dichloride) as the original application for treating metastatic castration-resistant prostate cancer with sy…

• FDA approval · 2013-04-25
  FDA Approved: JEVTANA — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2013-03-13
  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, representing a regulatory action…

• FDA approval · 2012-12-10
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  The U.S. FDA approved a supplemental application for ZYTIGA (abiraterone acetate) submitted by Janssen Biotech, Inc. The approval updates th…

• FDA approval · 2012-10-04
  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, signaling a regulatory update to the…

• FDA approval · 2012-09-17
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for ZYTIGA (abiraterone acetate) to expand its indication for metastatic castration-resistant pr…

• FDA approval · 2011-04-28
  FDA Approved: ZYTIGA — Original Application (Janssen Biotech, Inc.)

  FDA approves ZYTIGA (abiraterone acetate) under NDA 202379, marking the original approval for metastatic castration-resistant prostate cance…

• FDA approval · 2011-04-26
  FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for mitoxantrone hydrochloride from Fresenius Kabi USA, LLC. This approval encompasses the generic p…

• FDA approval · 2010-06-17
  FDA Approved: JEVTANA — Original Application (Sanofi-Aventis U.S. LLC)

  The FDA approved JEVTANA (cabazitaxel) in the original NDA submitted by Sanofi-Aventis U.S. LLC.