Prostate Cancer

• FDA approval · 2015-05-08
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Leuprolide acetate submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-03-20
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2015-03-03
  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 · 2015-02-27
  FDA Approved: CASODEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

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

• FDA approval · 2015-02-26
  FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA has approved a supplemental application for FIRMAGON (degarelix) from Ferring Pharmaceuticals Inc. to modify the existing approval.

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• FDA approval · 2015-02-03
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

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

• FDA approval · 2015-01-26
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  The FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., authorizing an update to th…

• FDA approval · 2015-01-23
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2015-01-20
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc. The action expands the product's…

• FDA approval · 2014-12-15
  FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for FIRMAGON (degarelix) by Ferring Pharmaceuticals Inc. This action represents an additional regula…

• FDA approval · 2014-11-10
  FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for FIRMAGON (degarelix) from Ferring Pharmaceuticals, potentially updating its labeling or expandin…

• FDA approval · 2014-11-05
  FDA Approved: DOCETAXEL — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves the original (ANDA) application for docetaxel generic produced by Dr. Reddy's Laboratories.

• FDA approval · 2014-10-10
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

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

• FDA approval · 2014-10-07
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  The FDA approved a supplemental application for ZOLADEX (goserelin) filed by TerSera Therapeutics LLC. This action typically updates labelin…

• FDA approval · 2014-09-10
  FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for XTANDI (enzalutamide) from Astellas Pharma US, Inc. This approval updates the product labeling/i…

• FDA approval · 2014-07-18
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approves a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval updates th…

• FDA approval · 2014-07-11
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

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

• FDA approval · 2014-07-10
  FDA Approved: DOCETAXEL — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for Docetaxel.

• FDA approval · 2014-05-23
  FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for XTANDI (enzalutamide) filed by Astellas Pharma US, expanding the labeling for the drug.

• FDA approval · 2014-05-15
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Docetaxel (Sanofi-Aventis U.S. LLC), indicating an approved modification to its labeling and…

• 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 · 2014-03-25
  FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Firmagon (degarelix) from Ferring Pharmaceuticals. The action updates the drug's labeling an…

• FDA approval · 2014-03-14
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

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

• 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.