Invasive Fungal Infections
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CLINICAL_TRIALS trial_result · 2022-10-06Clinical Trial Update: Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole [Phase 2, Phase 3]
A Phase 2/3 trial comparing SUBA-itraconazole to itraconazole for endemic mycoses in invasive fungal infections has completed with posted re…
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FDA approval · 2022-05-25FDA Approved: POSACONAZOLE — Original Application (Par Health USA, LLC)
FDA approved the original application for posaconazole (generic) by Par Health USA, LLC, marking the availability of a generic posaconazole …
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FDA approval · 2022-02-04FDA 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.
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FDA approval · 2021-12-14FDA 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…
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CLINICAL_TRIALS trial_result · 2021-07-14Clinical Trial Update: Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration [Phase 4]
Phase 4 trial updating fluconazole pharmacokinetics and bioavailability in obese subjects after intravenous and oral administration.
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FDA approval · 2021-02-01FDA Approved: POSACONAZOLE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved the original application for posaconazole from Lupin Pharmaceuticals, enabling generic availability of the antifungal.
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CLINICAL_TRIALS trial_result · 2020-01-23Clinical Trial Update: Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy [Phase 4]
Phase 4 clinical trial assessing effectiveness and efficiency of a voriconazole preemptive genotyping strategy for invasive fungal infection…
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FDA approval · 2018-11-30FDA Approved: VORICONAZOLE — Original Application (Slate Run Pharmaceuticals)
FDA approved voriconazole under an original application for Slate Run Pharmaceuticals.
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FDA approval · 2017-07-07FDA Approved: FLUCYTOSINE — Original Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' original application for Flucytosine (generic) to market the drug in the United States.
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CLINICAL_TRIALS trial_result · 2017-03-10Clinical Trial Update: Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections (Study P02387)
This is an update on a completed historical control study (P02387) of patients with invasive fungal infections who are refractory to or into…
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CLINICAL_TRIALS trial_result · 2017-03-10Clinical Trial Update: Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095) [Phase 3]
Phase 3 clinical trial P02095 evaluating posaconazole for invasive fungal infections has completed.
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CLINICAL_TRIALS trial_result · 2016-01-11Clinical Trial Update: Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi [Phase 3]
Phase 3 trial update evaluating isavuconazole for renally impaired patients with invasive aspergillosis and rare fungal infections; results …
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CLINICAL_TRIALS trial_result · 2016-01-06Clinical Trial Update: Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) [Phase 3]
A Phase 3 trial comparing oral posaconazole administered three times daily versus weekly high-dose amphotericin B lipid complex in patients …
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CLINICAL_TRIALS trial_result · 2015-12-31Clinical Trial Update: PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893) [Phase 2]
Phase 2 PK/PD study evaluating posaconazole for empiric treatment of invasive fungal infections in neutropenic patients and for treatment of…
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CLINICAL_TRIALS research · 2015-08-19Clinical Trial Update: Cost-Effectiveness of Amphotericin B
This clinical trial update assesses the cost-effectiveness of amphotericin B for invasive fungal infections, with the study status listed as…
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FDA approval · 2015-02-27FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for fluconazole from Rising Pharma Holdings, Inc. for a generic fluconazole product.
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FDA approval · 2014-10-23FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for CANCIDAS (caspofungin acetate) filed by Merck Sharp & Dohme LLC.
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CLINICAL_TRIALS trial_result · 2014-07-18Clinical Trial Update: A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
A Russian prospective observational study on invasive fungal infections in patients with acute leukemia undergoing hematopoietic stem cell t…
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520) [Phase 1]
Phase 1 study evaluating pharmacokinetics, safety, and tolerability of intravenous posaconazole followed by oral posaconazole suspension in …
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CLINICAL_TRIALS trial_result · 2013-10-18Clinical Trial Update: Perception and Prevalence of Fungal Infections in Berlin - Brandenburg
Charité University-sponsored Berlin-Brandenburg clinical trial on perception and prevalence of invasive fungal infections has completed.
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CLINICAL_TRIALS trial_result · 2013-03-28Clinical Trial Update: Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615) [Phase 1]
Phase 1 study evaluating the pharmacokinetics and safety of posaconazole tablets in participants at high risk for invasive fungal infections…
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CLINICAL_TRIALS research · 2013-01-17Clinical Trial Update: Invasive Fungal Infections Surveillance Initiative
This is a completed clinical trial update describing the Invasive Fungal Infections Surveillance Initiative sponsored by the University of P…
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CLINICAL_TRIALS research · 2012-09-12Clinical Trial Update: Registry of Febrile Neutropenia and Invasive Fungal Infections
This entry describes an ongoing registry tracking febrile neutropenia and invasive fungal infections in patients with hematologic diseases.
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CLINICAL_TRIALS trial_result · 2012-03-27Clinical Trial Update: Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU [Phase 3]
Phase 3 randomized trial comparing micafungin (FK463) to placebo for prophylaxis of invasive fungal infections in ICU patients; the study st…
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CLINICAL_TRIALS trial_result · 2011-12-14Clinical Trial Update: Anidulafungin PK in Infants and Toddlers [Phase 1]
A Phase 1 trial reports the pharmacokinetics of anidulafungin in infants and toddlers with invasive fungal infections. Results were posted o…