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City SANZ ET / / Company Swissmedic / Baxter Healthcare Corporation / Orgenus Pharma Inc. / Bristol-Myers Squibb / / Country United States / / Event FDA Phase / / IndustryTerm therapies for febrile neutropenia by the Infectious Diseases / letter concerning / / MedicalCondition acute bacterial arthritis / Pseudomonas / pneumonia / bacteremia / Lancet Infectious Diseases / Complicated Intra-abdominal Infections / Indications Pneumonia / skin and skin structure infections / neutropenic fever / febrile neutropenia studies / febrile neutropenia comparator patient death narratives / urinary tract/gynecologic infections / febrile neutropenia / nosocomial pneumonia / chronic respiratory tract infections / intraabdominal infections / skin infections / JOINT CLINICAL AND STATISTICAL REVIEW OF CEFEPIME AS EMPIRIC MONOTHERAPY FOR FEBRILE NEUTROPENIA / acute osteomyelitis / pyelonephritis / published febrile neutropenia study / soft tissue infections / MS / Complicated Urinary Tract Infections / intra-abdominal infections / infections / undiagnosed seizures/status epilepticus / / MedicalTreatment antibiotics / / MusicGroup Ph.D. / / OperatingSystem OSE / / Organization office of Surveillance and Epidemiology / FDA / Infectious Diseases Society of America / Anti-Infective Drug Products Advisory Committee / / Person Sanz / Quantitative Safety / Healthcare Informatics / Isidro Jarque / William Erhardt / Ana Szarfman / / Position Investigator / additional Medical Officer / EXECUTIVE / Premier / MEDICAL OFFICER / / Product ceftazidime / piperacillin / metronidazole / Maxipime / Pneumonia / AI411 / FIRST CEFEPIME / AI411-118 / / ProvinceOrState Alabama / / Technology Chemotherapy / /
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CLINICAL REVIEW Application Type Submission Number NDA