Briefing Materials for the July 9, 2025 Meeting of the Pediatric Advisory Committee

AUVI-Q AUTO-INJECTOR (epinephrine)

DENGVAXIA (Dengue Tetravalent Vaccine, Live)

DIOVAN (valsartan)

ENTRESTO (sacubitril and valsartan)

EPICEL (cultured epidermal autografts) (HDE)

ERAXIS (anidulafungin)

EUCRISA (crisaborole)

EXJADE (deferasirox), JADENU (deferasirox) and JADENU SPRINKLE (deferasirox)

FIASP (insulin aspart)

FLUZONE QUADRIVALENT (Influenza Vaccine)

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

JAKAFI (ruxolitinib phosphate) and OPZELURA (ruxolitinib)

LATUDA (lurasidone hydrochloride)

LILETTA (levonorgestrel-releasing intrauterine system)

LIPOSORBER LA-15 SYSTEM (Humanitarian Device Exemption (HDE))

MEDTRONIC ACTIVA NEUROSTIMULATOR FOR DYSTONIA TREATMENT (HDE)

MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM (HDE)

MYCAMINE (micafungin)

NITYR (nitisinone)

POTASSIUM PHOSPHATES (potassium phosphate, dibasic injection; potassium phosphate, monobasic)

REFLECT SCOLIOSIS CORRECTION SYSTEM (HDE)

REPATHA (evolocumab)

ROZLYTREK (entrectinib)

STELARA (ustekinumab)

SUTENT (sunitinib malate)

TASIGNA (nilotinib)

THE TETHER – VERTEBRAL BODY TETHERING SYSTEM (HDE)

TOPICORT (desoximetasone)

TRIUMEQ (abacavir, dolutegravir, lamivudine) and TRIUMEQ PD (abacavir, dolutegravir, lamivudine)

XYREM (sodium oxybate)