Advisory Committees
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Briefing Materials for the March 14, 2013 Meeting of the Pediatric Advisory Committee
Persons with disabilities having problems accessing any of the PDF files below may call (301) 796-3634 for assistance.
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Briefing Materials
Disclaimer: Portions of these documents have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. Sec. 552).
Actemra Safety Review (PDF - 136KB)- Actemra Use Review (PDF - 45KB)
Actemra Clinical Review (PDF - 1.4MB)- Actemra Pharmacology Review (PDF - 669KB)
- Actemra Statistical Review (PDF - 543KB)
- Actemra Labeling (10/11/2012)
- Article: macrophage activation syndrome as part of the systemic juevenile idiophathic arthritis: diagnosis, genetics, pathphysiology and treatment.
Almita Safety Review (PDF - 90KB)Almita Use Review (PDF - 51KB)- Almita Clinical Review (PDF - 632KB)
- Almita Pharmacology Review (PDF - 207KB)
- Almita Statistical Review (PDF - 364KB)
Almita Labeling (1/18/2013) Creon Safety and Use Review (PDF - 111KB)- Creon Clinical Review (PDF - 702KB)
- Creon Pharmacology Review (PDF - 58KB)
- Creon Statistical Review (PDF - 84KB)
- Creon Labeling (1/2012)
Gadavist Safety Review (PDF - 97KB)Gadavist Use Review (PDF - 25KB)- Gadavist Clinical Reviews (PDF - 989KB)
- Gadavist Pharmacology Review (PDF - 1.2MB)
- Gadavist Statistical Review (PDF - 375KB)
Gadavist Labeling (11/2011) Hizentra Safety and Use Review (PDF - 221KB)- Hizentra Clinical Review (9/26/2011) (PDF - 124KB)
- Hizentra Clinical Review (1/20/2011) (PDF - 228KB)
- Hizentra Statistical Review (PDF - 161KB)
- Hizentra Labeling (7/2012)
INOmax Safety Review (PDF - 1.1MB)- INOmax Use Review (PDF - 35KB)
- INOmax Device Safety Review (PDF - 102KB)
- INOmax Clinical Review (PDF - 1.1MB)
- INOmax Pharmacology Review (PDF - 45KB)
- INOmax Statistical Review (PDF - 612KB)
INOmax Labeling (3/2013) Article: Inhaled Nitric Oxided in Preterm Infants: A Systematic Review Invega Safety Review (PDF - 276KB)Invega Use Review (PDF - 90KB)Invega Safety and Use Review (2008) (PDF - 208KB)- Invega Clinical Review (PDF - 2.9MB)
- Invega Pharmacology Review (PDF - 447KB)
- Invega Statistical Review (PDF - 252KB)
- Invega Labeling (6/2011)
Kedbumin Safety and Use Review (PDF - 68KB)- Kedbumin Clinical Review (PDF - 314KB)
- Kedbumin Statistical Review (PDF - 85KB)
- Kedbumin Labeling (6/2012)
Kytril Injection Safety Review (PDF - 150KB)Kytril Injection Use Review (PDF - 201KB)Kytril 5HT3 Safety Review (PDF - 67KB)Kytril 5HT3 Use Review (PDF - 201KB)- Kytril Clinical Review (PDF - 409KB)
- Kytril Pharmacology Review (PDF - 17KB)
- Kytril Statistical Review (PDF - 38KB)
- Kytril Labeling (4/29/2011)
Article: The Serotonin Syndrome Lamictal XR Safety Review (PDF - 174KB)Lamictal XR Use Review (PDF - 177KB)- Lamictal XR Clinical Review (5/06/2009) (PDF - 52KB)
- Lamictal XR Clinical Review (4/25/2011) (PDF - 840KB)
- Lamictal XR Pharmacology Review (9/2007) (PDF - 2.5MB)
- Lamictal XR Pharmacology Review (4/2011) (PDF - 38KB)
- Lamictal XR Statistical Review (7/2008) (PDF - 226KB)
- Lamictal XR Statistical Review (4/2011) (PDF - 391KB)
- Lamictal XR Labeling (10/2012)
- Menactra Safety and Use Review (PDF - 220KB)
- Menactra Clinical Review (PDF - 331KB)
- Menactra Statistical Review (PDF - 526KB)
- Menactra Labeling (12/2011)
Moxeza Safety Reviews (PDF - 111KB)Moxeza Use Reviews (PDF - 57KB)- Moxeza Clinical Review (PDF - 615KB)
- Moxeza Pharmacology Review (PDF - 235KB)
- Moxeza Statistical Review (PDF - 580KB)
Moxeza Labeling (9/14/2012) Natroba Safety Review (PDF - 70KB)Natroba Use Review (PDF - 24KB)- Natroba Clinical Review (PDF - 166KB)
- Natroba Pharmacology Review (PDF - 50KB)
- Natroba Statistical Review (1/2011) (PDF - 46KB)
- Natroba Statistical Review (8/2010) (PDF - 28KB)
- Natroba Labeling (5/2011)
Nexium and Nexium IV Safety Review (PDF - 638KB)Nexium and Nexium IV Use Review (PDF - 242KB)- Nexium Clinical Review (PDF - 1.1MB)
- Nexium Pharmacology Review (PDF - 2MB)
- Nexium Statistical Review (PDF - 336KB)
Nexium Labeling (11/28/2012) - Nexium IV Clinical Review (PDF - 644KB)
- Nexium IV Pharmacology Review (PDF - 644KB)
Nexium IV Labeling (10/9/2012) Uroxatral Safety Review (PDF - 83KB)Uroxatral Use Review (PDF - 78KB)- Uroxatral Clinical Review (PDF - 850KB)
- Uroxatral Pharmacology Review (PDF - 942KB)
- Uroxatral Statistical Review (PDF - 447KB)
Uroxatral Labeling (10/2011) - Zenpep Safety and Use Review (PDF - 111KB)
- Zenpep Clinical Review (PDF - 2.3MB)
- Zenpep Pharmacology Review (PDF - 502KB)
- Zenpep Statistical Review (PDF - 377KB)
- Zenpep Labeling (7/12/2011)
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