Background Analysis: US FDA Advisory Committee to Review the Pediatric Safety of 18 Products Under BPCA/PREA/PMDSIA – SEP 16, 2015 (PEDAC)

The US FDA has scheduled a Pediatric Advisory Committee (PEDAC) meeting for Wednesday, September 16, 2015. The PEDAC will discuss 18 pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub.L.107-109) the Pediatric Research Equity Act (Pub.L.108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSIA). In particular, the PEDAC will discuss the following products: 1. DUREZOL (difluprednate ophthalmic emulsion) 0.05%, 2. ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), 3. BETHKIS (tobramycin Inhalation Solution), 4. INTELENCE (etravirine), 5. PREZISTA (darunavir), 6. VIRAMUNE XR (nevirapine), 7. EPIDUO (adapalene and benzoyl peroxide), 8. EXJADE (deferasirox), 9. DOTAREM (gadoterate meglumine), 10. FYCOMPA (perampanel), 11. RECOTHROM (thrombin, topical [recombinant]), 12. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), 13. PLEXIMMUNE, 14. ELANA SURGICAL KIT (HUD), 15. BERLIN HEART EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE (VAD), 16. ENTERRA THERAPY SYSTEM, 17. CONTEGRA Pulmonary Valved Conduit, and 18. Phenylephrine Hydrochloride Opthalmic Solution.

See the SAC Tracker report