Candidemia

• FDA approval · 2026-02-19
  FDA Approved: VFEND — Supplemental Application (Roerig)

  FDA approved a supplemental application for Vfend (voriconazole) submitted by Roerig.

• FDA approval · 2026-01-21
  FDA Approved: MICAFUNGIN — Original Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved Hisun Pharmaceuticals USA, Inc.'s original application for micafungin as a generic injectable antifungal. The approval covers u…

• FDA approval · 2025-11-14
  FDA Approved: VORICONAZOLE — Original Application (Hainan Poly Pharm. Co., Ltd.)

  The FDA approved a generic Voriconazole product from Hainan Poly Pharm. Co., Ltd. via an Original Application (ANDA 220043). It covers voric…

• FDA approval · 2025-07-23
  FDA Approved: MICAFUNGIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Micafungin (Hikma Pharmaceuticals USA Inc.), leading to changes/updates approved for this antifu…

• FDA approval · 2025-07-18
  FDA Approved: CASPOFUNGIN ACETATE — Original Application (Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.)

  The FDA approved Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.'s caspofungin acetate as an original generic application (ANDA) for mark…

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• FDA approval · 2025-04-03
  FDA Approved: MICAFUNGIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original ANDA for generic micafungin for the treatment of invasive candidiasis, candidemia, esophageal candidiasis, …

• FDA approval · 2023-09-29
  FDA Approved: MICAFUNGIN IN SODIUM CHLORIDE — Original Application (Baxter Healthcare Corporation)

  FDA approved a new intravenous micafungin sodium formulation under Baxter's Original Application NDA, expanding antifungal treatment options…

• FDA approval · 2023-03-22
  FDA Approved: REZZAYO — Original Application (Melinta Therapeutics, LLC)

  FDA approved the original application for REZZAYO (rezafungin) by Melinta Therapeutics for the treatment of candidemia and invasive candidia…

• FDA approval · 2022-12-14
  FDA Approved: VORICONAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Voriconazole from Sandoz Inc, approving a generic version of the antifungal medication.

• FDA approval · 2022-10-24
  FDA Approved: MICAFUNGIN — Original Application (Northstar Rx LLC.)

  FDA approved Northstar Rx LLC's original application for micafungin, a generic antifungal, for the treatment of invasive candidiasis includi…

• FDA approval · 2022-09-28
  FDA Approved: MICAFUNGIN — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' original application for micafungin sodium (micafungin) injection, a generic antifungal, for trea…

• FDA approval · 2022-06-13
  FDA Approved: VORICONAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Voriconazole from Zydus Lifesciences Limited, updating the approval for this generic antifun…

• FDA approval · 2022-05-09
  FDA Approved: VORICONAZOLE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' original application for a generic voriconazole product, enabling marketing of a generic antifung…

• FDA approval · 2021-07-09
  FDA Approved: MICAFUNGIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original ANDA for micafungin sodium injectable (micafungin).

• FDA approval · 2021-07-09
  FDA Approved: MICAFUNGIN — Original Application (Sagent Pharmaceuticals)

  FDA approved the Original Application for micafungin sodium from Sagent Pharmaceuticals, resulting in a generic micafungin product. The appr…

• FDA approval · 2021-06-16
  FDA Approved: MICAFUNGIN — Original Application (Par Health USA, LLC)

  FDA approved a micafungin product via an original NDA submitted by Par Health USA, LLC.

• FDA approval · 2020-10-05
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA approves a supplemental application for ERAXIS (anidulafungin) submitted by Roerig.

• FDA approval · 2020-07-31
  FDA Tentative Approval: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA granted tentative approval for a supplemental application for Mycamine (micafungin sodium) from Astellas Pharma US, enabling potenti…

• FDA approval · 2020-06-22
  FDA Approved: FLUCONAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fluconazole submitted by Chartwell RX, LLC.

• FDA approval · 2019-09-05
  FDA Approved: CASPOFUNGIN ACETATE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Caspofungin acetate submitted by Sagent Pharmaceuticals.

• FDA approval · 2019-05-17
  FDA Approved: MICAFUNGIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original ANDA for micafungin sodium (Micafungin), a generic echinocandin antifungal. The approval cov…

• FDA approval · 2018-03-13
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for Cancidas (caspofungin acetate) to update labeling and/or expand its indications, as part of Merc…

• FDA approval · 2018-01-05
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA approved a supplemental application for ERAXIS (anidulafungin) submitted by Roerig to update/expand the product labeling.

• FDA approval · 2016-05-31
  FDA Approved: VORICONAZOLE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approval of Lupin's original application for a generic voriconazole product used to treat invasive fungal infections, including invasive…

• FDA approval · 2015-09-02
  FDA Approved: VORICONAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original application for a generic Voriconazole (ANDA 203503), enabling the generic antifungal to be marketed in…