Mucormycosis

• FDA approval · 2022-02-04
  FDA Approved: POSACONAZOLE — Original Application (Biocon Phama Inc.)

  FDA approved Biocon Phama Inc.'s original application for posaconazole, authorizing a generic formulation of the antifungal agent.

• FDA approval · 2021-12-14
  FDA Approved: AMPHOTERICIN B — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' original application for Amphotericin B, confirming a generic version of the antifungal. The…

• FDA approval · 2021-12-09
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Cresemba (isavuconazonium sulfate) submitted by Astellas Pharma US, Inc.

• FDA approval · 2021-05-18
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Cresemba (isavuconazonium sulfate) filed by Astellas Pharma US, Inc. The approval adds to the ex…

• FDA approval · 2021-04-22
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved Astellas' supplemental application for Cresemba (isavuconazonium sulfate), finalizing changes to its labeling. The action u…

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• FDA approval · 2020-09-16
  FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved Merck's supplemental application for NOXAFIL (posaconazole), updating the product labeling with new indications/usage detai…

• FDA approval · 2016-01-05
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Cresemba (isavuconazonium sulfate) from Astellas Pharma US, expanding its approved indications. …

• FDA approval · 2015-04-03
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for CRESEMBA (isavuconazonium sulfate) from Astellas Pharma US, Inc., to support changes to the prod…

• FDA label_change · 2015-04-03
  FDA Approved: CRESEMBA — Supplemental Application (Astellas Pharma US, Inc.)

  FDA notice of a supplemental application for CRESEMBA (isavuconazonium sulfate) submitted by Astellas Pharma US, Inc., indicating a potentia…

• FDA approval · 2015-03-06
  FDA Approved: CRESEMBA — Original Application (Astellas Pharma US, Inc.)

  FDA approves Cresemba (isavuconazonium sulfate) under an original application for the treatment of invasive aspergillosis and mucormycosis.

• FDA approval · 2013-11-25
  FDA Approved: NOXAFIL — Original Application (Merck Sharp & Dohme LLC)

  FDA approves NOXAFIL (posaconazole) through Merck's original NDA. The approval recognizes posaconazole for prevention and treatment of invas…

• CLINICAL_TRIALS trial_result · 2011-10-06
  Clinical Trial Update: The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) Study [Phase 2]

  Phase 2 trial update for Deferasirox-AmBisome therapy in mucormycosis has completed with results posted in 2011.

• FDA approval · 2010-03-05
  FDA Approved: AMPHOTERICIN B — Supplemental Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved a supplemental application for Amphotericin B submitted by XGen Pharmaceuticals DJB, Inc. This approval authorizes a change to …

• FDA approval · 2006-09-15
  FDA Approved: NOXAFIL — Original Application (Merck Sharp & Dohme LLC)

  NOXAFIL (posaconazole) received FDA approval through its original application as a broad-spectrum antifungal agent for the prevention of inv…