Prostate Cancer

• FDA approval · 2013-09-12
  FDA Approved: CASODEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Casodex (bicalutamide) submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2013-04-25
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  The FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) by Verity Pharmaceuticals Inc.

• FDA approval · 2013-04-25
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approves Verity Pharmaceuticals' supplemental application for TRELSTAR (triptorelin pamoate).

• FDA approval · 2013-04-11
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., resulting in a label update und…

• FDA approval · 2013-03-19
  FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, expanding the labeling to include an …

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• 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 · 2013-03-12
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) submitted by Verity Pharmaceuticals Inc.

• FDA approval · 2013-03-12
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., indicating an updated labeling …

• FDA approval · 2013-03-05
  FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA approved a supplemental application for FIRMAGON (degarelix) submitted by Ferring Pharmaceuticals Inc., confirming an approved modif…

• FDA approval · 2013-02-27
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval pertains t…

• FDA approval · 2013-02-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) by URONOVA Pharmaceuticals.

• 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 · 2012-08-31
  FDA Approved: XTANDI — Original Application (Astellas Pharma US, Inc.)

  XTANDI (enzalutamide) received FDA approval via its original application for metastatic castration-resistant prostate cancer. This marks enz…

• FDA approval · 2012-07-20
  FDA Approved: BICALUTAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic bicalutamide.

• FDA approval · 2012-06-21
  FDA Approved: BICALUTAMIDE — Supplemental Application (Viona Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Bicalutamide by Viona Pharmaceuticals Inc.

• FDA approval · 2012-01-23
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Lupron Depot (leuprolide acetate) from AbbVie, resulting in an updated approval and labeling for…

• FDA approval · 2011-11-02
  FDA Approved: BICALUTAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Bicalutamide from Accord Healthcare Inc., updating its labeling.

• FDA approval · 2011-10-14
  FDA Approved: BICALUTAMIDE — Supplemental Application (Viona Pharmaceuticals Inc.)

  The FDA approved a supplemental application for bicalutamide submitted by Viona Pharmaceuticals Inc., updating the drug's labeling.

• FDA approval · 2011-06-30
  FDA Approved: BICALUTAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's Bicalutamide, resulting in updated labeling for this generic antiandrogen. …

• FDA approval · 2011-06-29
  FDA Approved: DOCETAXEL — Original Application (Baxter Healthcare Corporation)

  FDA approved the original application for docetaxel by Baxter Healthcare Corporation, marking its initial U.S. approval as a cancer therapy.…

• FDA approval · 2011-06-14
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) by AbbVie, expanding its approved indications and labeling.

• FDA approval · 2011-05-19
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triprorelin pamoate) submitted by Verity Pharmaceuticals Inc. The action indicates app…

• FDA approval · 2011-04-26
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Leuprolide Acetate from Sun Pharmaceutical Industries, resulting in changes to the product's…

• FDA approval · 2011-04-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) filed by Uronova Pharmaceuticals. This action approves the supplem…

• FDA approval · 2011-03-28
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc. for Leuprolide acetate (ANDA 074728).