Infective Endocarditis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-11-21FDA Approved: DAPTOMYCIN — Original Application (Par Health USA, LLC)
FDA approves the original application for daptomycin by Par Health USA, LLC, authorizing its use as an antibiotic for certain serious infect…
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CLINICAL_TRIALS trial_result · 2024-11-14Clinical Trial Update: Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis [NA]
A clinical trial is recruiting to compare antibiotics alone versus antibiotics plus surgical therapy for infective endocarditis.
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CLINICAL_TRIALS research · 2024-11-12Clinical Trial Update: Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) [NA]
This ClinicalTrials.gov entry reports the RECReATE study evaluating cytokine removal in critically ill patients undergoing surgery for infec…
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CLINICAL_TRIALS trial_result · 2024-09-26Clinical Trial Update: Early Feasibility Study of Somatostatin Receptors PET Imaging for the Diagnosis of Infective Endocarditis [Phase 2]
This update reports the completion of a Phase 2 feasibility study evaluating somatostatin receptor PET imaging for diagnosing infective endo…
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CLINICAL_TRIALS trial_result · 2024-09-04Clinical Trial Update: Management of Anemia in Patients with EndocaRditis Infectious Candidates for Cardiac Surgery: the AMERICA Study
A clinical trial update describes the AMERICA study investigating management of anemia in patients with Infective Endocarditis who are candi…
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FDA approval · 2024-08-29FDA Approved: DAPTOMYCIN — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s original application for daptomycin (DAPTOMYCIN), a generic antibiotic.
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CLINICAL_TRIALS research · 2024-07-12Clinical Trial Update: Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR）
ENDEAVOR is a clinical trial evaluating prognosis in infective endocarditis and exploring whether biomarkers can improve risk stratification…
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CLINICAL_TRIALS research · 2024-06-25Clinical Trial Update: The Incidence, Clinical Characteristics and Outcome of Infective Endocarditis Among Intravenous Drug Abusers Versus Non-Drug Abusers.
Assiut University is conducting a prospective clinical trial to compare the incidence, clinical characteristics, and outcomes of infective e…
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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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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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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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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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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 · 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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FDA approval · 2021-08-24FDA Approved: DAPTOMYCIN — Original Application (APOTEX CORP.)
FDA approved Apotex's Original Application for a generic version of daptomycin. The product is indicated for complicated skin and skin struc…
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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…
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FDA approval · 2021-05-05FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)
The FDA approved a supplemental application for Civica, Inc.'s daptomycin. This action approves an update requested in the supplemental subm…
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FDA approval · 2020-09-09FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for daptomycin (Hikma Pharmaceuticals USA Inc.), covering an additional formulation/strength under a…
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FDA approval · 2020-08-20FDA Approved: DAPTOMYCIN — Original Application (BE Pharmaceuticals Inc.)
The FDA approved BE Pharmaceuticals Inc.'s Original Application for Daptomycin (DAPTOMYCIN) as a generic antibiotic. The approval enables ge…
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FDA label_change · 2020-04-03FDA Approved: DAPTOMYCIN — Supplemental Application (Sagent Pharmaceuticals)
FDA notice of a supplemental application for Daptomycin submitted by Sagent Pharmaceuticals, with the submission status shown as AP.
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FDA approval · 2019-10-03FDA Approved: DAPTOMYCIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for daptomycin from Hikma Pharmaceuticals USA Inc. under ANDA206005. This represents a supplemen…
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FDA approval · 2019-09-18FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for Daptomycin from Civica, Inc., approving an update to its labeling or indication.