Esophageal Candidiasis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-03-14FDA Approved: FLUCONAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for fluconazole from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2015-02-03FDA Approved: VFEND — Supplemental Application (Roerig)
FDA approved a supplemental application for VFEND (voriconazole) from Roerig, resulting in an update/expansion of the product's labeling.
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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: Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis [Phase 3]
Phase 3 trial comparing micafungin to fluconazole for esophageal candidiasis has completed.
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CLINICAL_TRIALS trial_result · 2014-08-20Clinical Trial Update: Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug [Phase 1]
A Phase 1 study evaluating the safety and drug blood levels of micafungin (Mycamine) in infants and toddlers with invasive candidiasis, esop…
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CLINICAL_TRIALS trial_result · 2014-08-20Clinical Trial Update: Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis [Phase 3]
A Phase 3 trial comparing two dosing regimens of micafungin to caspofungin for esophageal candidiasis has completed.
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FDA approval · 2014-04-07FDA Approved: VFEND — Supplemental Application (Roerig)
FDA approved a supplemental application for VFEND (voriconazole) submitted by Roerig.
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FDA approval · 2014-03-28FDA Approved: ERAXIS — Supplemental Application (Roerig)
FDA's supplemental application for ERAXIS (anidulafungin) submitted by Roerig is noted as a supplemental approval action. The entry shows th…
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FDA approval · 2014-03-24FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)
The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride, an intravenous formulation of fluconazole.
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FDA approval · 2013-12-18FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC to update its labeling.
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FDA approval · 2013-01-08FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC, authorizing changes to the drug's l…
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FDA approval · 2012-05-30FDA Approved: VORICONAZOLE — Original Application (Sandoz Inc)
The FDA approved Sandoz Inc's original application for a generic Voriconazole, enabling its marketing in the United States for the same indi…
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CLINICAL_TRIALS trial_result · 2012-05-28Clinical Trial Update: A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066) [Phase 3]
Phase 3 trial results for caspofungin acetate (MK0991) in Chinese adults with esophageal candidiasis or invasive candidiasis were completed …
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FDA approval · 2012-03-14FDA Approved: FLUCONAZOLE — Supplemental Application (Hospira, Inc)
The FDA approved a supplemental application for fluconazole submitted by Hospira, Inc., authorizing changes to the product under the ANDA.
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FDA approval · 2012-01-30FDA Approved: FLUCONAZOLE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s generic fluconazole under Original Application (ANDA 078698). The approval covers multiple fun…
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FDA approval · 2012-01-25FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for fluconazole submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2011-10-13FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for fluconazole by Rising Pharma Holdings, Inc., authorizing an updated generic product under the AN…
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FDA approval · 2011-06-08FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for MYCAMINE (micafungin sodium) from Astellas Pharma US, Inc., updating its labeling with indicatio…
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FDA approval · 2011-03-07FDA Approved: FLUCONAZOLE — Original Application (ANI Pharmaceuticals, Inc.)
ANI Pharmaceuticals received FDA approval for an original generic application of fluconazole.
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FDA approval · 2010-11-21FDA Approved: VFEND — Supplemental Application (Roerig)
FDA approved a supplemental application for VFEND (voriconazole) submitted by Roerig. The supplement updates the labeling for the antifungal…
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FDA approval · 2009-09-18FDA Approved: FLUCONAZOLE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for fluconazole from Rising Pharma Holdings, Inc., enabling the generic antifungal to enter the market…
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FDA approval · 2009-07-30FDA Approved: FLUCONAZOLE — Original Application (Hospira, Inc)
FDA approved Hospira's original application for a generic fluconazole product, an antifungal medication with indications similar to the refe…
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FDA approval · 2009-05-04FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for Cancidas (caspofungin acetate) to expand its labeling.
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FDA approval · 2008-03-10FDA Approved: VFEND — Supplemental Application (Roerig)
FDA approved a supplemental application for VFEND (voriconazole) filed by Roerig.
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CLINICAL_TRIALS trial_result · 2007-10-02Clinical Trial Update: Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients [NA]
This clinical trial update reports on evaluating amphotericin B for biopsy-proven esophageal candidiasis in immunocompromised patients; the …