Briefing Materials for the November 13, 2025 Meeting of the Pediatric Advisory Committee

ABRAXANE (paclitaxel)
ARMONAIR RESPICLICK (fluticasone propionate), ARMONAIR DIGIHALER (fluticasone propionate), AIRDUO RESPICLICK (fluticasone propionate and salmeterol xinafoate), AIRDUO DIGIHALER (fluticasone propionate and salmeterol xinafoate)
AUBAGIO (teriflunomide)
AUSTEDO (deutetrabenazine)
BREXAFEMME (ibrexafungerp)
BYDUREON (exenatide), BYDUREON BCISE (exenatide), BYETTA (exenatide)
CIBINQO (abrocitinib)
CONTEGRA PULMONARY VALVED CONDUIT (HDE)
COSENTYX (secukinumab)
DESCOVY (emtricitabine and tenofovir alafenamide)
DUPIXENT (dupilumab)
EDURANT (rilpivirine), EDURANT PED (rilpivirine)
ENBREL (etanercept)
ENTERRA THERAPY SYSTEM (Humanitarian Device Exemption (HDE))
EVOTAZ (atazanavir and cobicistat)
LIALDA (mesalamine)
LINZESS (linaclotide)
LITFULO (ritlecitinib)
MYRBETRIQ EXTENDED-RELEASE TABLETS (mirabegron), MYRBETRIQ GRANULES (mirabegron)
NUCYNTA (tapentadol), NUCYNTA ER (tapentadol)
OPANA (oxymorphone hydrochloride)
PIFELTRO (doravirine), DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate)
PLEXIMMUNE (HDE)
QUELIMMUNE (HDE)
RAPIVAB (peramivir)
REXULTI (brexpiprazole)
RYALTRIS (olopatadine hydrochloride and mometasone furoate)
SELZENTRY (maraviroc)
SEVENFACT (coagulation factor VIIa (recombinant)-jncw)
SIMPONI ARIA (golimumab)
SMOFLIPID (lipid injectable emulsion)
SOLOSEC (secnidazole)
SONALLEVE MR-HIFU (HDE)
TAYTULLA (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules)
TEZSPIRE (tezepelumab-ekko)
TRINTELLIX (vortioxetine)
VAXCHORA (Cholera Vaccine, Live, Oral)
VIIBRYD (vilazodone hydrochloride)
XOFLUZA (baloxavir marboxil)
YCANTH (cantharidin)
ZEGALOGUE (dasiglucagon)
ZEPATIER (elbasvir and grazoprevir)
ZERBAXA (ceftolozane and tazobactam)
ZOSYN (piperacillin and tazobactam)