Briefing Materials for the September 15, 2020, Meeting of the Pediatric Advisory Committee
Vyvanse (lisdexamfetamine dimesylate)
- Vyvanse Clinical Pharmacology Review
- Vyvanse Clinical Review
- Vyvanse Labeling
- Vyvanse Safety and Utilization Review
Mydayis (mixed salts of a single-entity amphetamine)
- Mydayis Statistical Review
- Mydayis Clinical Pharmacology Review
- Mydayis Clinical Review
- Mydayis Labeling
- Mydayis Multidisciplinary Review Pediatric
- Adzenys Clinical Pharmacology Review
- Adzenys Clinical Review
- Adzenys Labeling
- Adzenys and Mydayis Safety and Utilization Review
Integrated Postmarket Safety Reviews
- ADHD Stimulants and Atomoxetine Integrated Postmarket Safety Review
- ADHD Stimulants and Atomoxetine & Antipsychotics Integrated Postmarket Safety Review
- Orencia Clinical Review
- Orencia Clinical Review Addendum
- Orencia Labeling
- Orencia Clinical Pharmacology Review 1
- Orencia Clinical Pharmacology Review 2
- Orencia Safety and Utilization Review
- Orencia Safety Signal Workup Review
Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)