Bacteremia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-06-05Clinical Trial Update: Antibiotic "Dysbiosis" in Preterm Infants [Phase 2]
Phase 2 clinical trial results for the antibiotic 'Dysbiosis' in preterm infants have been completed with results posted in 2024, evaluating…
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FDA approval · 2024-04-05FDA Approved: DAPTOMYCIN — Supplemental Application (BE Pharmaceuticals Inc.)
The FDA approves BE Pharmaceuticals Inc.'s supplemental application for daptomycin. This action updates the regulatory status for the drug u…
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CLINICAL_TRIALS trial_result · 2023-08-28Clinical Trial Update: Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs [Phase 3]
Phase 3 trial investigating pivmecillinam with amoxicillin/clavulanic acid for step-down oral therapy in ESBL urinary tract infections, curr…
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FDA approval · 2023-08-07FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)
FDA approves a generic version of daptomycin under an Original Application (ANDA) from Mylan Institutional LLC.
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FDA label_change · 2023-05-16FDA Approved: DAPTOMYCIN — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for daptomycin by Fresenius Kabi USA, LLC. The action typically results in labeling changes or new/c…
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CLINICAL_TRIALS trial_result · 2023-05-03Clinical Trial Update: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients [Phase 4]
Phase 4 clinical trial update on a strategy to prevent drug-induced nephrotoxicity in high-risk patients; the study was terminated with resu…
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CLINICAL_TRIALS trial_result · 2023-04-05Clinical Trial Update: Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections [Phase 4]
Phase 4 clinical trial evaluating intravenous immunoglobulin for donors to reduce donor-derived infections, with conditions including viremi…
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CLINICAL_TRIALS withdrawal · 2023-03-29Clinical Trial Update: Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia [Phase 4]
A Phase 4 clinical trial on therapeutic drug monitoring and continuous infusion of beta-lactam antibiotics for bacteremia was withdrawn.
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FDA approval · 2023-02-27FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for Daptomycin in Sodium Chloride from Baxter, authorizing a saline formulation of the antibiotic.
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CLINICAL_TRIALS trial_result · 2023-02-01Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex [Phase 3]
Phase 3 study evaluating intravenous sulbactam-ETX2514 for infections caused by Acinetobacter baumannii-calcoaceticus complex has completed …
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FDA approval · 2022-12-23FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)
FDA approves NorthStar RxLLC's generic daptomycin (DAPTOMYCIN) under an Original ANDA. The approval confirms the generic's indication for us…
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FDA approval · 2022-11-13FDA Approved: DAPTOMYCIN — Supplemental Application (BE Pharmaceuticals Inc.)
FDA approved a supplemental application for DAPTOMYCIN filed by BE Pharmaceuticals Inc. The approval relates to an ANDA and updates the regu…
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FDA approval · 2022-09-23FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)
The FDA approved the original application for daptomycin (generic) submitted by NorthStar RxLLC.
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CLINICAL_TRIALS trial_result · 2022-05-24Clinical Trial Update: An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures [Phase 4]
Phase 4 study evaluating an oral amoxicillin-clavulanate regimen to prevent bacteremia after dental procedures has been terminated.
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CLINICAL_TRIALS withdrawal · 2022-05-19Clinical Trial Update: Ceftolozane-tazobactam Versus Meropenem for ESBL and AmpC-producing Enterobacterales Bloodstream Infection [Phase 3]
Phase 3 trial comparing ceftolozane-tazobactam to meropenem for ESBL/AmpC-producing Enterobacterales bacteremia was withdrawn.
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CLINICAL_TRIALS research · 2022-04-25Clinical Trial Update: Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing [Phase 2]
Phase 2 clinical trial investigating bacteremia associated with tooth extractions and tooth brushing.
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FDA label_change · 2022-02-07FDA Approved: DAPTOMYCIN — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for daptomycin, resulting in labeling updates.
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FDA approval · 2022-01-25FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Original Application (Baxter Healthcare Corporation)
FDA approved Daptomycin in Sodium Chloride from Baxter Healthcare Corporation through an Original Application. The approval establishes a sa…
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FDA approval · 2021-11-18FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved vancomycin hydrochloride as a generic drug under an Original Application from Slate Run Pharmaceuticals, LLC.
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FDA approval · 2021-11-12FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (Plano Pharmaceuticals Inc.)
The FDA approved a supplemental application for Vancomycin hydrochloride by Plano Pharmaceuticals Inc., approving changes to the approved dr…
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FDA approval · 2021-10-26FDA Approved: ZYVOX — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for Zyvox (linezolid) from Pharmacia & Upjohn Company LLC.
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CLINICAL_TRIALS trial_result · 2021-09-22Clinical Trial Update: Prophylactic Antimicrobial Catheter Lock [Phase 4]
Phase 4 trial update for prophylactic antimicrobial catheter lock in patients with bacteremia; results posted after completion.
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FDA approval · 2021-09-02FDA Approved: DAPTOMYCIN — Original Application (Eugia US LLC)
FDA approved the original application for daptomycin for Eugia US LLC, authorizing clearance of a generic daptomycin product.
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CLINICAL_TRIALS trial_result · 2021-08-26Clinical Trial Update: Improving Dosing of Vancomycin in Young Infants With Infections [Phase 4]
Phase 4 trial update investigating improved dosing of vancomycin in young infants with infections.
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FDA approval · 2021-06-29FDA Approved: DAPTOMYCIN — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' generic daptomycin (daptomycin) under an original ANDA (ANDA 213623), authorizing its marketing a…