Presentations for the September 20, 2018 Meeting of the Pediatric Advisory Committee
Lexapro (escitalopram oxalate)
- Lexapro (escitalopram oxalate) Pediatric Safety and Utilization Review
- Drug-Ineffective Postmarketing Reports in Drug Safety Surveillance
- Generic Drug Development and Safety Evaluation
Intuniv (guanfacine ER)
Exjade/Jadenu (deferasirox)
- Deferasirox Pediatric Focused Safety Evaluation
- Deferasirox Assessment and Renal Injury
- Deferasirox-Associated Renal Toxicity
- Deferasirox: An Analysis of Pediatric Clinical Data and Pooled Analysis of Pediatric Clinical Study Data – Adverse Event Analysis
- Closing Comments
Product Updates
- Update on LABAs: Safety of Long Acting Beta Agonists (LABA)
- Update on Gadolinium: FDA Approach to Safety Issue of Gadolinium Retention After Administration of Gadolinium-based Contract Agents