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Chemistry / Herpesviruses / Antivirals / Purines / GlaxoSmithKline / Aciclovir / Valaciclovir / Chickenpox / Herpes zoster / Medicine / Viral diseases / Microbiology


1 OFFICE OF CLINICAL PHARMACOLOGY REVIEW NDA: 20-487, S-014 (Dosing in pediatric patients)
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Company

GlaxoSmithKline / AP Pharma Inc. / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

treatment of herpes / chemical / /

MedicalCondition

QD Herpes Labialis / renal insufficiency / HIV / chickenpox / herpes zoster / genital herpes / infection / herpes labialis / renal failure / infections / varicella / Herpes Zoster Genital Herpes / herpes simplex / zoster / herpes / cold sores / day Chickenpox / /

Organization

ND ND / OCP Division / Division of Clinical Pharmacology / OND Division / /

Person

Shirley K. Lu / Kellie S. Reynolds / /

Position

Major / Team Leader / General / officer / Executive / /

Product

CL / Zovirax / VALTREX / Valacyclovir / acyclovir / Valacyclovir Hydrochloride / Extemporaneous Oral Suspension / Adults / VACV / Apparent Oral / ACV / /

Technology

Geriatrics / pharmacokinetics / pharmacodynamics / /

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