Candidiasis
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Sign up freeTop drugs studied for this disease
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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 · 2021-11-02Clinical Trial Update: Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) [Phase 3]
A Phase 3 randomized study comparing fluconazole versus clotrimazole troches for preventing serious fungal infections in patients with AIDS …
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FDA approval · 2021-10-25FDA Approved: DIFLUCAN — Supplemental Application (Roerig)
The FDA approved a supplemental application for Diflucan (fluconazole) submitted by Roerig.
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FDA approval · 2021-10-06FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for fluconazole from Rising Pharma Holdings, Inc., related to this generic antifungal product.
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EMA withdrawal · 2021-08-20EMA Expired: Caspofungin Accord (caspofungin acetate) — Accord Healthcare S.L.U.
EU assessment indicates Caspofungin Accord has expired status and is no longer active on the market.
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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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FDA approval · 2021-01-14FDA Approved: NYSTATIN — Original Application (Macleods Pharmaceuticals Limited)
FDA approved an Original Application for NyStatin (nystatin) by Macleods Pharmaceuticals Limited, establishing a generic antifungal product.…
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FDA approval · 2020-09-16FDA 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…
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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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FDA approval · 2020-02-18FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)
The FDA approved a supplemental application for Ketoconazole filed by Thirty Madison Inc, resulting in updates to the Ketoconazole product l…
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CLINICAL_TRIALS trial_result · 2019-11-04Clinical Trial Update: Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections [Phase 4]
Phase 4 trial assessing boric acid with probiotics for vaginal infections including candidiasis and bacterial vaginosis; study completed wit…
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FDA approval · 2019-07-24FDA Approved: NYSTATIN — Original Application (Torrent Pharmaceuticals Limited)
FDA approved the Original Application for Nystatin from Torrent Pharmaceuticals Limited, authorizing a generic antifungal product.
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FDA approval · 2019-04-23FDA Approved: NYSTATIN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Nystatin ointment from Cosette Pharmaceuticals, Inc. The approval indicates regulatory clearance…
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CLINICAL_TRIALS trial_result · 2019-02-04Clinical Trial Update: Funguria in Hospitalized Patients
This document provides an update on a completed clinical trial evaluating funguria in hospitalized patients with candidiasis.
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FDA approval · 2018-06-18FDA Approved: KETOCONAZOLE — Original Application (Strides Pharma Science Limited)
FDA approved Strides Pharma Science Limited's original ANDA for Ketoconazole, a generic antifungal product, covering common dermatophytic an…
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CLINICAL_TRIALS trial_result · 2018-06-12Clinical Trial Update: Changing Patterns of Candida Infections in Urban Medical Centers
Completed clinical trial update examining changing patterns of Candida infections in urban medical centers, including non-albicans Candida s…
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FDA approval · 2018-05-25FDA Approved: NYSTATIN — Original Application (Viona Pharmaceuticals Inc)
FDA approved NYSTATIN as an Original Application (ANDA 207767) for a generic nystatin product by Viona Pharmaceuticals Inc.
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FDA approval · 2018-05-21FDA Approved: NYSTATIN — Original Application (Leading Pharma, LLC)
The FDA has approved an original ANDA for NYSTATIN from Leading Pharma, LLC.
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CLINICAL_TRIALS trial_result · 2018-01-10Clinical Trial Update: Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis [Phase 2]
Phase 2 study update for FK463 in candidemia or invasive candidiasis; the trial is completed.
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FDA approval · 2017-10-06FDA Approved: NYSTATIN — Original Application (Cosette Pharmaceuticals, Inc.)
FDA approved the original application for Nystatin Ointment from Cosette Pharmaceuticals, Inc., granting a new generic topical antifungal pr…
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FDA approval · 2017-09-26FDA Approved: NYSTATIN CREAM — Original Application (Crown Laboratories)
FDA approves Crown Laboratories' Nystatin Cream as an original generic topical antifungal (ANDA 207733) indicated for candidiasis, including…
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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 · 2017-07-02Clinical Trial Update: Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous. [NA]
The document summarizes a completed clinical trial evaluating disinfection solutions against Candida species from total prostheses (full den…
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FDA approval · 2017-06-08FDA Approved: NYSTATIN — Original Application (Zydus Lifesciences Limited)
FDA approves the original application for Nystatin from Zydus Lifesciences Limited.