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Pediatric Advisory Committee

November 18, 3008

BRIEFING INFORMATION

Cover Letter (pdf)

Zyprexa (olanzapine) Safety Review (pdf)
Zyprexa (olanzapine) Use Review (pdf)
Zyprexa (olanzapine) BPCA Clinical Review Summary (pdf)
Zyprexa (olanzapine) BPCA Clin Pharm Review Summary (pdf)
Zyprexa (olanzapine) Labeling (pdf)

Risperdal (risperidone) Safety Review (pdf)
Risperdal (risperidone) Use Review (pdf)
Risperdal (risperidone) BPCA Clinical Review Summary (pdf)
Risperdal (risperidone) BPCA Clin Pharm Review Summary (pdf)
Risperdal (risperidone) Labeling (pdf)

Levaquin (levofloxacin) Safety Review (pdf)
Levaquin (levofloxacin) Use Review (pdf)
Levaquin (levofloxacin) BPCA Clinical Review Summary (pdf)
Levaquin (levofloxacin) BPCA Clin Pharm Review Summary (pdf)
Levaquin (levofloxacin) Quinalone Public Health Advisory July 8, 2008 (pdf)
Levaquin (levofloxacin) Labeling (pdf)

Ambien (zolpidem) Safety Review (pdf)
Ambien (zolpidem) Use Review (pdf)
Ambien (zolpidem) BPCA Clinical Review Summary (pdf)
Ambien (zolpidem) BPCA Clin Pharm Review Summary (pdf)
Ambien (zolpidem) OSE Addendum (pdf)
Ambien (zolpidem) OPT Integrated Safety Summary (pdf)
Ambien (zolpidem) Labeling (pdf)

Lamictal (Lamotrigine) Graphics for deaths and serious AEs with  Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (pdf)
Lamictal (Lamotrigine) Safety Review (pdf)
Lamictal (Lamotrigine) Use Review (pdf)
Lamictal (Lamotrigine) BPCA Clinical Review and Clin Pharm Review Summary (pdf)
Medication Error Safety Review (pdf)
Lamictal (Lamotrigine) Healthcare Information Sheet–Suicidality and Antiepileptic Drugs (pdf)
Lamictal (Lamotrigine) Labeling (pdf)
 
Aldara (imiquimod) Safety Review (pdf)
Aldara (imiquimod) Use Review (pdf)
Aldara (imiquimod) BPCA Clinical Review Summary (pdf)
Aldara (imiquimod) BPCA Clin Pharm Review Summary (pdf)
Aldara (imiquimod) Labeling (pdf)

Lamisil (terbinafine) Safety Review (pdf)
Lamisil (terbinafine) Use Review (pdf)
Lamisil (terbinafine) BPCA Clinical Review Summary (pdf)
Lamisil (terbinafine) Link to full Clinical Review (pdf)
Lamisil (terbinafine) BPCA Clin Pharm Review Summary (pdf)
Lamisil (terbinafine) Link to full Clin Pharm Review (pdf)
Lamisil (terbinafine) BPCA Statistical Review Summary (pdf)
Lamisil (terbinafine) Link to full Statistical Review (pdf)
Lamisil (terbinafine) Medication Error Postmarketing Safety Review (pdf)
Lamisil (terbinafine) Labeling (Oral granules) (pdf)
Lamisil (terbinafine) Labeling (Tablets) (pdf)

Sandostatin (octreotide) Safety Review 2008 (pdf)
Sandostatin (octreotide) Slides from April 2007 (pdf)
Sandostatin (octreotide) Safety Review from April 2007 (pdf)
Sandostatin (octreotide) Reference (Pediatr Crit Care Med 2006 Nov 7 (6):576-9 (p777)) (pdf)
Sandostatin (octreotide) Labeling (LAR Depot Injection) (pdf)
Sandostatin (octreotide) Labeling (Solution, Injection) (pdf)

Betoptic S (betaxolol) Safety Review (pdf)
Betoptic S (betaxolol) Use Review (pdf)
Betoptic S (betaxolol) BPCA Clinical Review Summary (pdf)
Betoptic S (betaxolol) Labeling (pdf)

Timolol GFS (timolol) Safety Review (pdf)
Timolol GFS (timolol) Use Review (pdf)
Timolol GFS (timolol) BPCA Clinical Review Summary (pdf)
Timolol GFS (timolol) Labeling (pdf)

Zyvox (linezolid) Cover Memo (pdf)
Zyvox (linezolid) OSE Report (pdf)
Zyvox (linezolid) OSE Follow-Up (pdf)
Zyvox (linezolid) PAC Link to November, 2006 (pdf)
Zyvox (linezolid) Labeling (pdf)

Pediatric Ethics Subcommittee June 9-10, 2008 Federal Register Notice (pdf)
Pediatric Ethics Subcommittee June 9-10, 2008 MeetingAgenda (pdf)
Pediatric Ethics Subcommittee June 9-10, 2008 Meeting Roster (pdf)

Pediatric Ethics Subcommittee June 9-10, 2008 Meeting Minutes (pdf)

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