| Document Date: 2006-11-13 08:05:15
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City Ann Arbor / / Company Pfizer Inc. / / Country United States / / Event FDA Phase / / IndustryTerm study protocol / / MedicalCondition pneumonia / CSF shunt infections / bacteremia / headache / strain / resistant Enterococcal infections / vancomycin-resistant Enterococcus faecium infections / CSF infections / nausea / skin rash / thrombocytopenia / severe life threatening infections / diabetic foot infections / documented VRE infections / fever / resistant Enterococcus faecium infections / vomiting / culture-confirmed VRE infections / skin structure infections / nosocomial pneumonia / concomitant osteomyelitis / suspected resistant Gram-positive infections / skin infections / central nervous system infections / VRE infection / concurrent bacteremia Nosocomial Pneumonia / diarrhea / infection / Community-acquired pneumonia / concurrent bacteremia / infections / concurrent bacteremia Uncomplicated SSSI / Infection Complicated SSSI* Community-acquired pneumonia / anemia / pancytopenia / / MedicalTreatment catheter / antibiotics / oral therapy / / Organization FDA / EXECUTIVE SUMMARY Division of Anti-Infective and Ophthalmology Products Summary / FDA Pediatric Exclusivity Board / / Person Alfred Sorbello / Janice Soreth / Sumathi Nambiar / / Position Executive / OFFICER / / Product Linezolid / Intravenous solution Oral Tablet Oral Suspension / cefadroxil / Clinical Program Linezolid / Zyvox / United States / vancomycin / Zyvox™ / / ProvinceOrState Pennsylvania / Georgia / Michigan / / Technology study protocol / pharmacokinetics / / URL http /
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http://www.fda.gov/cder/foi/esum/2005/021130s009,021131s010,021132s009_Linezolid_Clinical_BPCA.pdf