Prostate Cancer

• 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.

• 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 · 2021-07-01
  FDA Approved: DOCETAXEL — Original Application (Gland Pharma Limited)

  FDA approves Gland Pharma Limited's generic docetaxel as an Original Application, adding a new generic option for cancer chemotherapy.

• FDA approval · 2021-05-26
  FDA Approved: PYLARIFY — Original Application (Progenics Pharmaceuticals, Inc.)

  FDA approves PYLARIFY (piflufolastat F-18) as an original NDA for PET imaging to detect suspected recurrent prostate cancer in adults.

• FDA approval · 2021-05-24
  FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for XTANDI (enzalutamide) from Astellas Pharma US, Inc., marking an update to the drug's labeling.

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• FDA approval · 2021-05-21
  FDA Approved: AXUMIN — Supplemental Application (Blue Earth Diagnostics)

  FDA approved a supplemental application for AXUMIN (fluciclovine F-18) submitted by Blue Earth Diagnostics, resulting in updated labeling th…

• 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 (NORTHSTAR RX LLC)

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

• FDA approval · 2021-02-01
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Leuprolide acetate submitted by Sandoz Inc. This action approves changes under the generic d…

• FDA approval · 2021-01-14
  FDA Approved: DOCETAXEL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for generic docetaxel. Docetaxel is a chemotherapy agent used to treat mu…

• FDA approval · 2020-12-18
  FDA Approved: ORGOVYX — Original Application (Sumitomo Pharma America, Inc.)

  The FDA approved ORGOVYX (relugolix) under an original NDA submitted by Sumitomo Pharma America, marking the approval of a new treatment opt…

• 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 · 2020-12-01
  FDA Approved: GALLIUM GA-68 PSMA-11 — Original Application (UCSF Radiopharmaceutical Facility)

  FDA approved Gallium-68 PSMA-11 (gallium-68 gozetotide) for PET imaging to detect PSMA-expressing lesions in adult men with suspected prosta…

• FDA approval · 2020-12-01
  FDA Approved: GALLIUM GA-68 PSMA-11 — Original Application (UCLA Biomedical Cyclotron)

  FDA approved Gallium-68 PSMA-11 (Gallium-68 gozetotide) for PET imaging of PSMA-expressing lesions in men with suspected metastatic prostate…

• 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 · 2020-10-20
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Zoledronic acid from Hikma Pharmaceuticals USA Inc., indicating regulatory approval for the spon…

• 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 · 2020-09-10
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC.

• FDA approval · 2020-09-04
  FDA Approved: NILUTAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for nilutamide, confirming regulatory approval for an updated product submiss…

• 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 · 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 · 2020-03-18
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) submitted by AbbVie Inc.

• FDA approval · 2020-02-24
  FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Firmagon (degarelix) from Ferring Pharmaceuticals Inc., resulting in an updated label for th…