Bladder Cancer

• FDA approval · 2025-06-12
  FDA Approved: ZUSDURI — Original Application (UroGen Pharma, Inc)

  FDA approves ZUSDURI (mitomycin) from UroGen Pharma under an original NDA, marking its first approval for use in bladder cancer.

• FDA approval · 2024-09-24
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Teyro Labs Private Limited)

  FDA approved a supplemental application for Gemcitabine hydrochloride from Teyro Labs Private Limited, authorizing continued approval of thi…

• FDA approval · 2024-05-10
  FDA Approved: CISPLATIN — Original Application (Apotex Corp.)

  FDA approved the original application for cisplatin from Apotex Corp., enabling the generic version to be marketed in the United States.

• FDA approval · 2023-09-19
  FDA Approved: DOCETAXEL — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's supplemental application to manufacture and market a generic docetaxel, enabling its supply for cancer treatment i…

• FDA approval · 2023-03-07
  FDA Approved: GEMCITABINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic gemcitabine under an Original Application (ANDA). This marks the approval of a generic…

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• FDA approval · 2020-12-11
  FDA Approved: GEMCITABINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic gemcitabine hydrochloride under an original ANDA.

• FDA approval · 2020-10-06
  FDA Approved: GEMCITABINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for gemcitabine from Fresenius Kabi USA, approving a generic gemcitabine product under ANDA 090799. …

• FDA approval · 2019-10-03
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for gemcitabine hydrochloride from Gland Pharma Limited. This approval enables the marketing of …

• FDA approval · 2018-07-20
  FDA Approved: GEMCITABINE — Original Application (Sagent Pharmaceuticals)

  FDA approves Sagent Pharmaceuticals' original ANDA for gemcitabine, a generic injectable chemotherapy used to treat several cancers.

• FDA approval · 2017-11-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for doxorubicin hydrochloride from BluePoint Laboratories, adding a new approved generic version of …

• FDA approval · 2017-08-03
  FDA Approved: GEMCITABINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's gemcitabine injectable drug as an original application, providing a generic version of the anticancer agent…

• FDA approval · 2017-03-17
  FDA Approved: CISPLATIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for cisplatin, a generic injectable chemotherapy agent (ANDA approval).

• FDA approval · 2017-01-19
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC.

• FDA approval · 2016-11-17
  FDA Approved: GEMCITABINE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for gemcitabine under ANDA 079183. This represents approval of a supplemental submissi…

• FDA approval · 2016-07-29
  FDA Approved: CYSVIEW — Supplemental Application (Photocure Inc.)

  The FDA has approved a supplemental application for CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) from Photocure Inc.

• FDA approval · 2016-01-26
  FDA Approved: GEMCITABINE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' supplemental application for gemcitabine hydrochloride (gemcitabine), enabling continued producti…

• FDA approval · 2014-11-05
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for doxorubicin hydrochloride (Fresenius Kabi USA, LLC) under anANDA to support its generic product.

• FDA approval · 2014-01-17
  FDA Approved: VALSTAR — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for VALSTAR (valrubicin) from Endo USA, Inc., potentially expanding or updating its labeling for use…

• FDA approval · 2013-11-12
  FDA Approved: VALSTAR — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for VALSTAR (valrubicin) submitted by Endo USA, Inc.

• FDA approval · 2013-02-04
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Original Application (BluePoint Laboratories)

  FDA approved a generic doxorubicin hydrochloride product under Original Application for BluePoint Laboratories (ANDA 203263). This marks app…

• FDA approval · 2012-12-20
  FDA Approved: VALSTAR — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for VALSTAR (valrubicin) from Endo USA, Inc., supporting updated labeling and/or indications for int…

• FDA approval · 2012-11-28
  FDA Approved: CYSVIEW — Supplemental Application (Photocure Inc.)

  The FDA approved a supplemental application for CYSVIEW (hexaminolevulinate hydrochloride) from Photocure Inc., expanding its labeling/indic…

• FDA approval · 2012-11-13
  FDA Approved: CISPLATIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for cisplatin filed by Fresenius Kabi USA, LLC. This action confirms the continued approval of cispl…

• FDA approval · 2012-03-15
  FDA Approved: CISPLATIN — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for cisplatin from Teva Parenteral Medicines, Inc., marking an approved change to the drug's regulat…

• FDA approval · 2011-11-02
  FDA Approved: VALSTAR — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for VALSTAR (valrubicin) from Endo USA, Inc., updating or expanding its labeling related to its …