Table I.

Included Drugs and Drug/Study Characteristics

Drug	Drug Class	Route of Administration	Predominant Route of Elimination	Pediatric Trial Phase	Ages Studied (years)	Ages Approved (years)
Adefovir	Antiviral	Oral	Renal unchangeda	1/2	12–17	12–17
Amoxicillin Clavulanate XR	Antibacterial	Oral	Renal unchanged	1	7–15	7–15
Atazanavirb,c	Antiviral	Oral	Hepatic then fecalg	1/2; 3b	6–17; 0.25–5	6–17; 0.25–5
Azithromycin	Antibacterial	Oral	Other	1	0.5–16	0.5–16
Caspofungind	Antifungal	Intravenous	Hepatic then renal	1	0.25–11	0.25–17
Darunavire	Antiviral	Oral	Hepatic then fecalg	1,2	3–17	3–17
Dolutegravir	Antiviral	Oral	Feces unchanged	1/2	12–17	12–17
Efavirenzf	Antiviral	Oral	Hepatic then fecalg	1/2	0.25–2	0.25–2
Emtricitabinef	Antiviral	Oral	Renal unchangeda	1	0–0.25	0–0.25
Entecavir	Antiviral	Oral	Renal unchanged	2	2–15	2–15
Ertapenem	Antibacterial	Intravenous	Hepatic then renal	1	0.25–17	0.25–17
Etravirine	Antiviral	Oral	Hepatic then fecalg	1	6–17	6–17
Famciclovir	Antiviral	Oral	Hepatic then renal	1/2	0.083–12	None
Fosamprenavirf	Antiviral	Oral	Hepatic then fecalg	2	0.08–5	0.08–5
Levofloxacin	Antibacterial	Oral/Intravenous	Renal unchanged	1	0.5–17	0.5–17
Linezolid	Antibacterial	Intravenous	Hepatic then renal	1	0–17	0–17
Lopinavir/Ritonavirf	Antiviral	Oral	Hepatic then fecalg	1/2	0.04–0.5; 13–17	0.04–0.5; 13–17
Micafungin	Antifungal	Intravenous	Hepatic then renal	1	0.33–16	0.33–16
Nelfinavird,f	Antiviral	Oral	Hepatic then fecalg	1	0–1	None
Oseltamivir	Antiviral	Oral	Hepatic then renal	1	1–17	1–17
PEG-Interferon alfa-2b	Antiviral	Subcutaneous	Hepatic then renal	1/3	3–17	3–17
Raltegravir	Antiviral	Oral	Hepatic then fecalg	1/2	2–17	2–17
Ritonavir	Antiviral	Oral	Hepatic then fecalg	1/2	0.08–1	0.08–1
Tenofovire	Antiviral	Oral	Renal unchangeda	3	2–17	2–17
Terbinafine	Antifungal	Oral	Hepatic then renal	1/2	4–17	4–17
Tipranavir	Antiviral	Oral	Hepatic then fecalg,h	1/2	2–17	2–17
Valacyclovir	Antiviral	Oral	Renal unchangeda	1	1–17	1–17
Valgancyclovir	Antiviral	Oral	Hepatic then renal	1	0.33–16	0.33–16

^aAdministered as prodrug and active metabolite eliminated in the urine, largely unchanged

^bTwo applications submitted to expand the pediatric indication.

^cAtazanavir without ritonavir evaluated separately from atazanavir with ritonavir.

^dAges studied and ages approved do not match.

^eOne new application submitted; a second application to expand the pediatric indication.

^fPurpose of the application was to expand the pediatric indication.

^gSome hepatic metabolism with primary excretion into feces; also unchanged drug eliminated in feces.

^hWhen administered with ritonavir, there is minimal metabolism.