Complicated Intra-abdominal Infections
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CLINICAL_TRIALS research · 2026-03-23Clinical Trial Update: Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE
This clinical trial update reports ongoing real-world evaluation of the aztreonam-avibactam combination against metallo-beta-lactamase-produ…
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CLINICAL_TRIALS research · 2025-10-29Clinical Trial Update: A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI) [Phase 2]
A Phase 2 pediatric trial is evaluating the safety and tolerability of eravacycline in children aged 8 to 17 with complicated intra-abdomina…
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CLINICAL_TRIALS trial_result · 2025-09-04Clinical Trial Update: Real-World Study of Ceftazidime Avibactam in China
Real-world study of ceftazidime-avibactam in China was terminated, with results posted, evaluating its use for hospital-acquired pneumonia, …
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FDA approval · 2025-08-06FDA Approved: TIGECYCLINE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for tigecycline from Apotex Corp, indicating an approved addition or update under the supplemental f…
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CLINICAL_TRIALS trial_result · 2021-10-22Clinical Trial Update: Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015) [Phase 3]
Phase 3 trial comparing ceftolozane/tazobactam plus metronidazole to meropenem for complicated intra-abdominal infections has completed with…
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FDA approval · 2020-04-09FDA Approved: TIGECYCLINE — Supplemental Application (Sandoz Inc)
FDA approved Sandoz Inc's supplemental application for tigecycline, a generic antibiotic. This action concerns the ANDA for tigecycline (AND…
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FDA label_change · 2019-09-20FDA Approved: ERTAPENEM — Supplemental Application (ENDO USA, Inc.)
The FDA approved a supplemental application for ertapenem (ERTAPENEM SODIUM) submitted by ENDO USA, Inc.
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FDA approval · 2019-06-11FDA Approved: TIGECYCLINE — Original Application (Eugia US LLC)
FDA approved the original application for a generic tigecycline product by Eugia US LLC, enabling market availability of a generic tigecycli…
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FDA approval · 2019-03-19FDA Approved: ERTAPENEM — Original Application (Apotex Corp)
FDA approved Apotex Corp's original application for ertapenem sodium (ertapenem), a broad-spectrum carbapenem antibiotic, as a generic produ…
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CLINICAL_TRIALS trial_result · 2019-03-04Clinical Trial Update: Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE) [Phase 2]
Phase 2 trial assessing pharmacokinetics, safety, and tolerability of ATM-AVI for complicated intra-abdominal infections in hospitalized adu…
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CLINICAL_TRIALS trial_result · 2019-02-18Clinical Trial Update: Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections [Phase 3]
A Phase 3 study comparing eravacycline to meropenem in complicated intra-abdominal infections has completed with posted results.
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FDA approval · 2018-12-21FDA Approved: TIGECYCLINE — Original Application (Apotex Corp)
FDA approves Apotex Corp's original application for tigecycline, granting approval of a generic version of the antibiotic.
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CLINICAL_TRIALS trial_result · 2018-08-09Clinical Trial Update: Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs). [Phase 2]
Phase 2 trial evaluating safety, pharmacokinetics, and efficacy of CAZ-AVI with metronidazole in children with complicated intra-abdominal i…
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FDA approval · 2018-08-02FDA Approved: TIGECYCLINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original application for tigecycline, authorizing a generic injectable antibiotic. It covers indic…
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CLINICAL_TRIALS trial_result · 2018-02-27Clinical Trial Update: Antibiotic Safety (SCAMP) [Phase 2, Phase 3]
Phase 2/Phase 3 clinical trial update for an antibiotic safety study (SCAMP) in complicated intra‑abdominal infections; results posted in 20…
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CLINICAL_TRIALS trial_result · 2016-05-30Clinical Trial Update: Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Clinical trial evaluating the safety and effectiveness of tigecycline in subjects with complicated skin and skin structure infections and co…
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CLINICAL_TRIALS trial_result · 2016-03-21Clinical Trial Update: Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections [Phase 3]
Phase 3 trial comparing eravacycline to ertapenem for complicated intra-abdominal infections completed.
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CLINICAL_TRIALS safety_alert · 2011-07-08Clinical Trial Update: Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
Post-marketing safety study of tigecycline (Tygacil) completed; results posted, evaluating safety in patients with complicated skin and skin…
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FDA approval · 2007-04-03FDA Approved: TYGACIL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for TYGACIL (tigecycline) by Wyeth Pharmaceuticals (a Pfizer subsidiary), indicating regulatory …