Invasive Candidiasis

• EMA approval · 2026-06-15
  EMA Authorised: Rezzayo (rezafungin) — Mundipharma GmbH

  EMA authorised Rezzayo (rezafungin) for candidiasis and invasive candidiasis, marketed by Mundipharma GmbH.

• EMA approval · 2026-04-08
  EMA Authorised: Rezzayo (rezafungin) — Mundipharma GmbH

  The European Medicines Agency authorized Rezzayo (rezafungin) from Mundipharma GmbH for the treatment of candidiasis, including invasive can…

• 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 · 2026-01-14
  FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride (intravenous formulation), adding this generic IV flu…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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…

• 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 · 2024-10-25
  FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for NOXAFIL (posaconazole) from Merck Sharp & Dohme LLC.

• FDA approval · 2024-05-29
  FDA Approved: MICAFUNGIN — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s original ANDA for micafungin, a generic antifungal. The approval covers indications including candidiasis …

• FDA approval · 2023-12-26
  FDA Approved: POSACONAZOLE — Original Application (Mylan Institutional LLC)

  FDA approves a generic posaconazole product from Mylan Institutional LLC under an Original Application (ANDA 211500). The approval indicates…

• 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 · 2023-07-14
  FDA Approved: FLUCONAZOLE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter Healthcare Company's supplemental application for fluconazole (ANDA076766). This action confirms authorization of a gene…

• 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 · 2023-03-17
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for fluconazole submitted by Rising Pharma Holdings, Inc., indicating approval of a generic formulat…

• 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 · 2021-10-25
  FDA Approved: DIFLUCAN — Supplemental Application (Roerig)

  The FDA approved a supplemental application for Diflucan (fluconazole) submitted by Roerig.

• 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.