Invasive Candidiasis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-10-05FDA Approved: ERAXIS — Supplemental Application (Roerig)
FDA approves a supplemental application for ERAXIS (anidulafungin) submitted by Roerig.
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FDA approval · 2020-07-31FDA 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…
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FDA approval · 2020-06-22FDA Approved: FLUCONAZOLE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for fluconazole submitted by Chartwell RX, LLC.
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CLINICAL_TRIALS trial_result · 2020-01-13Clinical Trial Update: Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis [Phase 2]
Phase 2 clinical trial update for Amphotericin B cholesteryl sulfate complex for injection (ABCD) in invasive candidiasis and invasive asper…
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FDA approval · 2019-09-05FDA Approved: CASPOFUNGIN ACETATE — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for Caspofungin acetate submitted by Sagent Pharmaceuticals.
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FDA approval · 2019-07-16FDA Approved: FLUCONAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Fluconazole from Zydus Lifesciences Limited, resulting in regulatory approval of this generic pr…
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FDA approval · 2019-05-17FDA 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…
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CLINICAL_TRIALS trial_result · 2018-09-14Clinical Trial Update: Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis [Phase 3]
Phase 3 clinical trial update on anidulafungin for invasive candidiasis in children has completed with posted results.
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CLINICAL_TRIALS trial_result · 2018-08-28Clinical Trial Update: Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064) [Phase 2]
A Phase 2 trial comparing caspofungin to amphotericin B deoxycholate for invasive candidiasis in neonates and infants was terminated; result…
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CLINICAL_TRIALS trial_result · 2018-08-24Clinical Trial Update: Invasive Candidiasis in Saudi ICUs
Clinical trial update for invasive candidiasis in Saudi ICUs; study completed with results posted in 2018.
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FDA approval · 2018-03-13FDA 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…
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FDA approval · 2018-01-05FDA Approved: ERAXIS — Supplemental Application (Roerig)
FDA approved a supplemental application for ERAXIS (anidulafungin) submitted by Roerig to update/expand the product labeling.
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CLINICAL_TRIALS trial_result · 2017-08-01Clinical Trial Update: Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections [Phase 3]
Phase 3 trial evaluating isavuconazole (BAL8557) for candidemia and invasive candidiasis; results were posted in 2017.
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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 · 2017-05-03Clinical Trial Update: Variability of Fluconazole Concentration in Critically Ill Patients
This clinical trial update reports variability in fluconazole concentrations among critically ill patients with invasive candidiasis and dis…
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CLINICAL_TRIALS trial_result · 2017-04-05Clinical Trial Update: Impact of a Loading Dose of Caspofungin in Invasive Candidiasis in ICU Patients
The clinical trial evaluated the impact of a caspofungin loading dose in ICU patients with invasive candidiasis. The study status is complet…
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CLINICAL_TRIALS trial_result · 2017-01-12Clinical Trial Update: Pharmacokinetics of Micafungin in Critically Ill Patients
This clinical trial update reports the completed pharmacokinetic study of micafungin in critically ill patients. The trial focused on pharma…
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FDA approval · 2016-12-30FDA Approved: CASPOFUNGIN ACETATE — Original Application (Fresenius Kabi USA, LLC)
FDA approved caspofungin acetate for the treatment of invasive candidiasis (including candidemia) and esophageal candidiasis.
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CLINICAL_TRIALS safety_alert · 2016-02-04Clinical Trial Update: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
A Pfizer-sponsored trial in invasive candidiasis evaluated the risk of severe hepatic injury with echinocandins. The study was terminated an…
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CLINICAL_TRIALS trial_result · 2015-10-30Clinical Trial Update: Optimal Dosage of Caspofungin in Critically Ill Patients [Phase 4]
A Phase 4 trial evaluating the optimal dosage of caspofungin in critically ill patients with suspected invasive candidiasis has completed.
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CLINICAL_TRIALS trial_result · 2015-09-21Clinical Trial Update: A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis [Phase 3]
A Phase 3 randomized trial comparing anidulafungin to fluconazole for candidemia and invasive candidiasis was terminated; results were poste…
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CLINICAL_TRIALS research · 2015-04-03Clinical Trial Update: Candida Spp. in the Lower Respiratory Tract: Harmless Residents or Pathogen?
Clinical trial update examining whether Candida species in the lower respiratory tract are harmless residents or pathogens. The conditions s…
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CLINICAL_TRIALS trial_result · 2015-03-24Clinical Trial Update: Empirical Antifungal Treatment in ICUS [Phase 3]
A Phase 3 clinical trial evaluating empirical antifungal treatment for invasive candidiasis has completed.
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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 · 2014-09-18Clinical Trial Update: Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia [Phase 3]
Phase 3 trial comparing micafungin to liposomal amphotericin B (AmBisome) for invasive candidiasis and candidemia has completed.