cyclic lipopeptide antibiotic
Daptomycin updates
Answer
24 changes for Daptomycin in the last 12 months. Latest: 2026-09-09.
| Date | Type | What changed | Source |
|---|---|---|---|
| 2026-09-09 | Recall | FDA recall, Class II: Baxter Healthcare Corporation. CGMP Deviations | Regulator FDA enforcement reports |
| 2026-09-09 | Recall | FDA recall, Class II: Baxter Healthcare Corporation. CGMP Deviations | Regulator FDA enforcement reports |
| 2026-08-26 | Label | FDA label revised: Daptomycin (ANDA216413) | Regulator FDA drug label register |
| 2026-08-06 | Label | FDA label revised: Daptomycin (NDA208385) | Regulator FDA drug label register |
| 2026-07-21 | Label | FDA label revised: Daptomycin (NDA208385) | Regulator FDA drug label register |
| 2026-06-30 | Shortage | FDA shortage status to be discontinued: Daptomycin, Injection, 500 mg/10 mL (NDC 0143-9378-01) | Regulator FDA drug shortages |
| 2026-06-30 | Shortage | FDA shortage status to be discontinued: Daptomycin, Injection, 500 mg/10 mL (NDC 57884-3151-1) | Regulator FDA drug shortages |
| 2026-05-08 | Label | FDA label revised: Daptomycin (NDA210282) | Regulator FDA drug label register |
| 2026-05-05 | Results | Results posted: Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL) | Trial register ClinicalTrials.gov |
| 2026-04-23 | Label | FDA label revised: Daptomycin (ANDA216413) | Regulator FDA drug label register |
| 2026-04-23 | Label | FDA label revised: Daptomycin (ANDA216413) | Regulator FDA drug label register |
| 2026-04-13 | Label | FDA label revised: Daptomycin (ANDA216445) | Regulator FDA drug label register |
| 2026-04-09 | Label | FDA label revised: Daptomycin (NDA217415) | Regulator FDA drug label register |
| 2026-03-23 | Label | FDA label revised: Daptomycin (NDA209949) | Regulator FDA drug label register |
| 2026-03-09 | Label | FDA label revised: DAPTOMYCIN (ANDA213786) | Regulator FDA drug label register |
| 2026-02-17 | Label | FDA label revised: DAPTOMYCIN (ANDA213623) | Regulator FDA drug label register |
| 2026-02-17 | Label | FDA label revised: DAPTOMYCIN (ANDA213623) | Regulator FDA drug label register |
| 2026-01-30 | Label | FDA label revised: Daptomycin (ANDA208375) | Regulator FDA drug label register |
| 2026-01-21 | Trial | New trial registered: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia | Trial register ClinicalTrials.gov |
| 2025-12-18 | Label | FDA label revised: Daptomycin (NDA217415) | Regulator FDA drug label register |
| 2025-12-08 | Label | FDA label revised: DAPTOMYCIN (ANDA213786) | Regulator FDA drug label register |
| 2025-10-24 | Label | FDA label revised: daptomycin (ANDA212513) | Regulator FDA drug label register |
| 2025-10-09 | Label | FDA label revised: DAPTOMYCIN (ANDA211961) | Regulator FDA drug label register |
| 2025-10-09 | Label | FDA label revised: Daptomycin (ANDA212667) | Regulator FDA drug label register |
| 2025-09-10 | Label | FDA label revised: DAPTOMYCIN (ANDA213623) | Regulator FDA drug label register |
| 2025-09-08 | Label | FDA label revised: daptomycin (ANDA205037) | Regulator FDA drug label register |
| 2025-08-29 | Label | FDA label revised: Daptomycin (ANDA217215) | Regulator FDA drug label register |
| 2025-08-29 | Label | FDA label revised: daptomycin (ANDA213425) | Regulator FDA drug label register |
| 2025-08-26 | Results | Results posted: Comparing Oral Versus Parenteral Antimicrobial Therapy | Trial register ClinicalTrials.gov |
| 2025-08-23 | Trial | New trial registered: In Vivo Antibiotics Removal During Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit | Trial register ClinicalTrials.gov |
| 2025-08-22 | Trial | New trial registered: Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? | Trial register ClinicalTrials.gov |
| 2025-08-19 | Label | FDA label revised: Daptomycin (NDA217630) | Regulator FDA drug label register |
| 2025-08-15 | Label | FDA label revised: daptomycin (ANDA213966) | Regulator FDA drug label register |
| 2025-07-30 | Label | FDA label revised: Daptomycin (ANDA206005) | Regulator FDA drug label register |
| 2025-07-16 | Label | FDA label revised: Daptomycin (NDA217630) | Regulator FDA drug label register |
| 2025-06-30 | Label | FDA label revised: Daptomycin (ANDA208375) | Regulator FDA drug label register |
| 2025-06-16 | Label | FDA label revised: Daptomycin (ANDA215316) | Regulator FDA drug label register |
| 2025-05-06 | Results | Results posted: A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia | Trial register ClinicalTrials.gov |
| 2025-04-30 | Label | FDA label listed: Daptomycin in Sodium Chloride | Company says FDA drug label register |
| 2025-04-28 | Trial | New trial registered: Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Co | Trial register ClinicalTrials.gov |
| 2025-04-09 | Federal Register | Federal Register notice: 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comment | Regulator Federal Register |
| 2025-03-10 | Trial | New trial registered: Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria | Trial register ClinicalTrials.gov |
| 2025-03-07 | Trial | New trial registered: Antibiotic Impregnated Beads in Osteomyelitis | Trial register ClinicalTrials.gov |
| 2025-02-07 | Label | FDA label revised: daptomycin (ANDA215890) | Regulator FDA drug label register |
| 2024-11-18 | Trial | New trial registered: Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia | Trial register ClinicalTrials.gov |
| 2024-10-22 | Results | Results posted: DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia | Trial register ClinicalTrials.gov |
| 2024-10-15 | Trial | New trial registered: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia | Trial register ClinicalTrials.gov |
| 2024-05-24 | Label | FDA label revised: Daptomycin (NDA217415) | Regulator FDA drug label register |
| 2024-05-13 | Trial | New trial registered: Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis. | Trial register ClinicalTrials.gov |
| 2024-04-08 | Label | FDA label revised: Daptomycin (NDA209949) | Regulator FDA drug label register |
| 2024-04-05 | Label | FDA label revised: Daptomycin (NDA209949) | Regulator FDA drug label register |
| 2024-03-18 | Results | Results posted: Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment | Trial register ClinicalTrials.gov |
| 2024-03-12 | Results | Results posted: PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN | Trial register ClinicalTrials.gov |
| 2024-01-19 | Label | FDA label revised: Daptomycin (ANDA215316) | Regulator FDA drug label register |
| 2024-01-05 | Trial | New trial registered: Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial | Trial register ClinicalTrials.gov |
| 2023-11-17 | Label | FDA label revised: Daptomycin (ANDA206005) | Regulator FDA drug label register |
| 2023-11-14 | Label | FDA label revised: daptomycin (ANDA215890) | Regulator FDA drug label register |
| 2023-11-13 | Label | FDA label revised: Daptomycin (ANDA206005) | Regulator FDA drug label register |
| 2023-11-01 | Federal Register | Federal Register notice: Determination That CALCIUM DISODIUM VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were N | Regulator Federal Register |
| 2023-09-25 | Label | FDA label revised: DAPTOMYCIN (ANDA213171) | Regulator FDA drug label register |
| 2023-08-07 | Federal Register | Federal Register notice: Determination That CUBICIN (Daptomycin) Powder for Injection, 250 Milligrams/Vial and 500 Milligrams/Vial, and CUBICIN RF (Daptomycin) Powder for | Regulator Federal Register |
| 2023-08-07 | Trial | New trial registered: Comparing Oral Versus Parenteral Antimicrobial Therapy | Trial register ClinicalTrials.gov |
| 2023-08-04 | Label | FDA label revised: Daptomycin (ANDA206005) | Regulator FDA drug label register |
| 2023-05-06 | Results | Results posted: Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia | Trial register ClinicalTrials.gov |
| 2023-05-03 | Results | Results posted: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients | Trial register ClinicalTrials.gov |
| 2023-04-19 | Label | FDA label revised: Daptomycin (ANDA216445) | Regulator FDA drug label register |
| 2023-03-08 | Recall | FDA recall, Class II: Accord Healthcare, Inc.. CGMP Deviations: recalling drug products following an FDA inspection. | Regulator FDA enforcement reports |
| 2023-03-08 | Recall | FDA recall, Class II: Accord Healthcare, Inc.. CGMP Deviations: recalling drug products following an FDA inspection. | Regulator FDA enforcement reports |
| 2023-02-22 | Recall | FDA recall, Class II: Sentara Infusion Services. Lack of sterility assurance | Regulator FDA enforcement reports |
| 2023-02-22 | Recall | FDA recall, Class II: Sentara Infusion Services. Lack of sterility assurance | Regulator FDA enforcement reports |
| 2023-01-25 | Recall | FDA recall, Class I: Accord Healthcare, Inc.. Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial | Regulator FDA enforcement reports |
| 2022-11-30 | Label | FDA label revised: Daptomycin (ANDA206077) | Regulator FDA drug label register |
| 2022-10-01 | Label | FDA label revised: daptomycin (ANDA215890) | Regulator FDA drug label register |
| 2022-06-09 | Label | FDA label revised: Daptomycin (ANDA206077) | Regulator FDA drug label register |
| 2022-05-17 | Label | FDA label revised: daptomycin (ANDA207104) | Regulator FDA drug label register |
| 2022-04-29 | Label | FDA label revised: Daptomycin (ANDA206005) | Regulator FDA drug label register |
| 2022-02-04 | Trial | New trial registered: A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia | Trial register ClinicalTrials.gov |
| 2022-02-04 | Trial | New trial registered: Utility Assessment of a Pharmacy-to-Dose Daptomycin | Trial register ClinicalTrials.gov |
| 2022-01-28 | Federal Register | Federal Register notice: 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comment | Regulator Federal Register |
| 2022-01-25 | Label | FDA label revised: DAPZURA RT (NDA213645) | Regulator FDA drug label register |
| 2021-12-14 | Trial | New trial registered: Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL) | Trial register ClinicalTrials.gov |
| 2021-11-30 | Trial | New trial registered: Staphylococcus Aureus Network Adaptive Platform Trial | Trial register ClinicalTrials.gov |
| 2021-11-18 | Federal Register | Federal Register notice: Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications | Regulator Federal Register |
| 2021-11-10 | Recall | FDA recall, Class I: MERCK SHARP & DOHME CORP. Presence of Particulate Matter: Identified as Glass Particles | Regulator FDA enforcement reports |
| 2021-10-04 | Label | FDA label revised: Daptomycin (ANDA211403) | Regulator FDA drug label register |
| 2021-07-30 | Trial | New trial registered: PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN | Trial register ClinicalTrials.gov |
| 2021-06-21 | Trial | New trial registered: Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections | Trial register ClinicalTrials.gov |
| 2021-03-30 | Results | Results posted: Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI | Trial register ClinicalTrials.gov |
| 2021-03-26 | Results | Results posted: Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections | Trial register ClinicalTrials.gov |
| 2021-03-01 | Trial | New trial registered: DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia | Trial register ClinicalTrials.gov |
| 2021-02-08 | Results | Results posted: Catheter Related - Gram Positive Bloodstream Infections | Trial register ClinicalTrials.gov |
| 2020-10-22 | Federal Register | Federal Register notice: 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comment | Regulator Federal Register |
| 2020-09-14 | Trial | New trial registered: The Efficacy and Safety of Daptomycin in the Treatment of Gram-positive Bacterial Infection. | Trial register ClinicalTrials.gov |
| 2020-08-12 | Recall | FDA recall, Class I: Mylan Institutional LLC. Presence of Particulate Matter | Regulator FDA enforcement reports |
| 2020-06-16 | Trial | New trial registered: Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC) | Trial register ClinicalTrials.gov |
| 2020-06-04 | Trial | New trial registered: Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin | Trial register ClinicalTrials.gov |
| 2020-03-18 | Recall | FDA recall, Class II: Redline Pharmacy Solutions. Lack Of Processing Controls | Regulator FDA enforcement reports |
| 2020-03-06 | Trial | New trial registered: Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI | Trial register ClinicalTrials.gov |
| 2020-02-28 | Results | Results posted: Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis | Trial register ClinicalTrials.gov |
| 2020-02-20 | Trial | New trial registered: A Pharmacokinetics Study of Daptomycin in Critically Ill Patients and Effects of Daptomycin on Kidney | Trial register ClinicalTrials.gov |
The 100 newest of 241 are listed.
From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.
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