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One Year Post Exclusivity Adverse Event Review: Atovaquone-Proguanil Pediatric Advisory Committee Meeting February 14, 2005
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Document Date: 2005-08-08 12:20:59


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Company

GlaxoSmithKline / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

prevention of malaria / Malaria Treatment / Treatment of malaria / /

MedicalCondition

fever / Stevens-Johnson syndrome / falciparum malaria / abdominal pain / vomiting / urticaria / erythema multiforme / headache / seizures / malaria / diarrhea / P. falciparum malaria / Cough / hallucinations / rash / pruritis / acute P. falciparum malaria / acute uncomplicated P. falciparum malaria / /

Organization

Pediatric Drug Development Center for Drug Evaluation / Atovaquone-Proguanil Pediatric Advisory Committee / Food and Drug Administration / FAAP Medical Officer Division / /

Person

Alan M. Shapiro / /

Product

Malarone Pediatric / Dispensed prescriptions / Malarone / Indication / /

Technology

Drug Development / /

SocialTag