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Chemistry / Organic chemistry / Piperazines / Reverse-transcriptase inhibitor / Hepatitis B / Norfloxacin / Adverse Event Reporting System / Purines / Gilead Sciences / Adefovir


Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology
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City

Atlanta / /

Company

Gilead Sciences Inc. / Alteon Inc. / /

Country

Germany / United States / Ukraine / /

Event

FDA Phase / /

IndustryTerm

treatment of HIV / food / /

MedicalCondition

incoordination / omphalocele / PDA / HBeAg- chronic hepatitis B / HIV / disease / umbilical hernia / HBV / patent ductus arteriosus / dysfunction / muscle weakness / Hepatitis B / lamivudine-resistant hepatitis B / birth defect / lactic acidosis / lower extremity muscle weakness / human hepatitis B / histologically active disease / infection / lower extremity incoordination / hepatitis / MS / liver disease / chronic hepatitis B / /

OperatingSystem

OSE / /

Organization

office of New Drugs / office of Surveillance and Epidemiology / Division of Pharmacovigilance / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / office of Surveillance / office of Pediatric Therapeutics / FDA / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / /

Person

Ann W. McMahon / Lisa L. Mathis / Melissa M. Truffa / M. Dianne Murphy / Evelyne T. Edwards / /

/

Position

contractor / Acting Director / MA Postmarketing Safety Evaluator / Associate Director / EXECUTIVE / Safety Evaluator Team Leader / physician / CONTENTS EXECUTIVE / Director Pediatric and Maternal Health Staff / /

Product

Hepsera / lamivudine / Hepsera® (adefovir dipivoxil) Tablets / /

Technology

pharmacokinetics / PDA / MRI / /

SocialTag