FDA Pediatric Advisory Committee (PAC) Meeting | July 9

Agenda

‘The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 9, 2025, the Pediatric Advisory Committee (PAC) will meet to discuss post-marketing pediatric-focused safety reviews as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109), the Pediatric Research Equity Act of 2003 (Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (Pub. L. 110-85, title III).

‘The PAC will have the opportunity to ask the Agency clarifying questions and to convey their recommendations for safety monitoring of the products listed below. The scope of the discussion will be limited to post-marketing safety and surveillance activities. No information is required from product sponsors.’

The PAC will meet to discuss the following products listed by FDA Center:

1. Center for Devices and Radiological Health

a. LIPOSORBER LA-15 SYSTEM (Humanitarian Device Exemption (HDE)) b. MEDTRONIC ACTIVA NEUROSTIMULATOR FOR DYSTONIA TREATMENT (HDE) c. MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM (HDE) d. REFLECT SCOLIOSIS CORRECTION SYSTEM (HDE) e. THE TETHER – VERTEBRAL BODY TETHERING SYSTEM (HDE)

2. Center for Biologics Evaluation and Research

a. DENGVAXIA (Dengue Tetravalent Vaccine, Live) b. EPICEL (cultured epidermal autografts) (HDE) c. FLUZONE QUADRIVALENT (Influenza Vaccine) d. GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

3. Center for Drug Evaluation and Research

a. AUVI-Q AUTO-INJECTOR (epinephrine) b. DIOVAN (valsartan) c. ENTRESTO (sacubitril and valsartan) d. ERAXIS (anidulafungin) e. EUCRISA (crisaborole) f. EXJADE (deferasirox), JADENU (deferasirox) and JADENU SPRINKLE (deferasirox) g. FIASP (insulin aspart) h. JAKAFI (ruxolitinib phosphate) and OPZELURA (ruxolitinib) i. LATUDA (lurasidone hydrochloride) j. LILETTA (levonorgestrel-releasing intrauterine system) k. MYCAMINE (micafungin) l. NITYR (nitisinone) m. POTASSIUM PHOSPHATES (potassium phosphate, dibasic injection; potassium phosphate, monobasic) n. REPATHA (evolocumab) o. ROZLYTREK (entrectinib) p. STELARA (ustekinumab) q. SUTENT (sunitinib malate) r. TASIGNA (nilotinib) s. TOPICORT (desoximetasone) t. TRIUMEQ (abacavir, dolutegravir, lamivudine) and TRIUMEQ PD (abacavir, dolutegravir, lamivudine) u. XYREM (sodium oxybate)