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Levofloxacin / Ofloxacin / Quinolone / New Drug Application / Norfloxacin / Adverse effects of fluoroquinolones / Piperazines / Chemistry / Organic chemistry


Document Date: 2009-04-02 10:58:03

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City

Rockville / /

Company

S-013 Ortho-McNeil Pharmaceutical Inc. / Johnson & Johnson Pharmaceutical Research & Development LLC / Johnson & Johnson / /

Event

FDA Phase / /

IndustryTerm

supplemental new drug applications / drug product / supplemental applications / healthcare / /

MedicalCondition

loss of consciousness / acute liver failure / bronchospasm / airway obstruction / occasionally fatal hypersensitivity / vasculitis / arthralgia / dyspnea / leukopenia / shortness of breath / severe tendon disorders / acute hepatic necrosis / Serious acute hypersensitivity / tendonitis / QTc prolongation/torsades de pointes / thrombotic thrombocytopenic purpura / skin rash / thrombocytopenia / toxic epidermal necrolysis / itching / fever / Stevens-Johnson Syndrome / acute severe liver injury / seizure / acute renal insufficiency / pain / serum sickness / StevensJohnson Syndrome / allergic pneumonitis / acute respiratory distress / hepatic failure / urticaria / angioedema / interstitial nephritis / bradycardia / hypotension/shock / fainting spells / hypersensitivity / anaphylactic reactions / serious tendon disorders / hepatitis / inflammation / hypokalemia / rash / anemia / myocardial ischemia / agranulocytosis / pancytopenia / /

MedicalTreatment

antibiotics / /

Movie

Page 3 2 / /

Organization

Food and Drug Administration / Special Pathogen and Transplant Products Office / Antimicrobial Products Center for Drug Evaluation and Research Enclosure / DEPARTMENT OF HEALTH / Division of Special Pathogen / /

Person

Renata Albrecht / Cynthia Chianese / Kristen Miller / /

/

Position

Director / Regulatory Affairs / Director / physician / Regulatory Health Project Manager / M.D. Director / /

Product

levofloxacin / epinephrine / dextrose / Levaquin / S-048 / S-045 / stop taking LEVAQUIN / Levaquin® (levofloxacin) Tablets / HFD-001 / /

ProvinceOrState

New Jersey / Maryland / /

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