Agenda:

‘On November 13, 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:

Center for Devices and Radiological Health

• ENTERRA THERAPY SYSTEM (Humanitarian Device Exemption (HDE))
• CONTEGRA PULMONARY VALVED CONDUIT (HDE)
• PLEXIMMUNE (HDE)
• SONALLEVE MR-HIFU (HDE)

Center for Biologics Evaluation and Research

• QUELIMMUNE (HDE)
• SEVENFACT (coagulation factor VIIa (recombinant)-jncw)
• VAXCHORA (Cholera Vaccine, Live, Oral)

Center for Drug Evaluation and Research

• 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)
• COSENTYX (secukinumab)
• DESCOVY (emtricitabine and tenofovir alafenamide)
• DUPIXENT (dupilumab)
• EDURANT (rilpivirine), EDURANT PED (rilpivirine)
• ENBREL (etanercept)
• 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)
• RAPIVAB (peramivir)
• REXULTI (brexpiprazole)
• RYALTRIS (olopatadine hydrochloride and mometasone furoate)
• SELZENTRY (maraviroc)
• SIMPONI ARIA (golimumab)
• SMOFLIPID (lipid injectable emulsion)
• SOLOSEC (secnidazole)
• TAYTULLA (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules)
• TEZSPIRE (tezepelumab-ekko)
• TRINTELLIX (vortioxetine)
• VIIBRYD (vilazodone hydrochloride) \
• XOFLUZA (BALOXAVIR MARBOXIL)
• YCANTH (cantharidin)
• ZEGALOGUE (DASIGLUCAGON)
• ZEPATIER (elbasvir and grazoprevir)
• ZERBAXA (ceftolozane and tazobactam)
• ZOSYN (piperacillin and tazobactam)