Prostate Cancer

• FDA approval · 2019-12-27
  FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP. The approval updates the product labeli…

• 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 · 2019-11-04
  FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal Pharmaceuticals NY LLC's supplemental application for Abiraterone acetate, authorizing the manufacture and sale of a gen…

• 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 · 2019-09-17
  FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)

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

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• FDA approval · 2019-09-05
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for docetaxel (docetaxel anhydrous) by Mylan Institutional LLC under ANDA 210072.

• 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 · 2019-04-16
  FDA Approved: BICALUTAMIDE — Supplemental Application (Viona Pharmaceuticals Inc.)

  FDA approved a supplemental application for bicalutamide filed by Viona Pharmaceuticals Inc.

• FDA approval · 2019-04-01
  FDA Approved: DOCETAXEL — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Docetaxel from Dr. Reddy's Laboratories Inc., authorizing the generic product under the approved…

• FDA approval · 2019-03-13
  FDA Approved: DOCETAXEL ANHYDROUS — Supplemental Application (Meitheal Pharmaceuticals Inc)

  The FDA approved a supplemental application from Meitheal Pharmaceuticals to market docetaxel anhydrous as a generic chemotherapy drug.

• FDA approval · 2019-03-04
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie 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…

• FDA approval · 2019-02-15
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals, resulting in changes to the labeling…

• FDA approval · 2019-01-07
  FDA Approved: ABIRATERONE ACETATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic abiraterone acetate product, expanding access to treatment f…

• FDA approval · 2018-12-10
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) submitted by AbbVie, resulting in a labeling update via a supp…

• FDA approval · 2018-10-31
  FDA Approved: ABIRATERONE ACETATE — Original Application (Apotex Corp.)

  FDA approved Abiraterone acetate (generic) from Apotex Corp. under an original ANDA, enabling a generic version of the cancer drug for metas…

• FDA approval · 2018-10-31
  FDA Approved: ABIRATERONE ACETATE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan's original application for Abiraterone acetate, enabling a generic version of the cancer drug used for metastatic cas…

• FDA approval · 2018-10-31
  FDA Approved: ABIRATERONE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic abiraterone acetate product (ABIRATERONE) for the treatment…

• 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 · 2018-05-22
  FDA Approved: YONSA — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approval of Sun Pharmaceutical Industries' YONSA (abiraterone acetate) under an Original Application for the treatment of prostate cance…

• 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 · 2018-02-14
  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 · 2018-02-07
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ZYTIGA (abiraterone acetate) from Janssen Biotech, Inc., indicating an approved update to the pr…

• FDA approval · 2017-11-01
  FDA Approved: CASODEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for CASODEX (bicalutamide) submitted by ANI Pharmaceuticals, Inc. This action updates the regula…

• FDA approval · 2017-08-09
  FDA Approved: DOCETAXEL — Original Application (Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

  FDA approved a generic version of docetaxel under an original ANDA from Jiangsu Hengrui Pharmaceuticals Co., Ltd., enabling market authoriza…