Food and Drug Administration

Pediatric Advisory Committee

February 14, 2005

Slides

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

One Year Post Exclusivity Adverse Event Review: Benazepril, Dr. Lawrence Grylack, MD (PPT) (PDF)

One Year Post Exclusivity Adverse Event Review: Esmolol, Dr. Lawrence Grylack, MD (PPT) (PDF)

One Year Post Exclusivity Adverse Event Review: Orlistat, Dr. Hari Sachs, MD, FAAP (PPT) (PDF)

One Year Post Exclusivity Adverse Event Review: Glyburide-Metformin, Dr. Hari Sachs, MD, FAAP (PPT) (PDF)

One Year Post Exclusivity Adverse Event Review: Atovaquone-Proguanil, Dr. Alan Shapiro, MD, PhD, FAAP (PPT) (PDF)

One Year Post Exclusivity Adverse Event Review: Nelfinavir Mesylate, Dr. Alan Shapiro, MD, PhD, FAAP (PPT) (PDF)

Adverse Event Review and Reporting as Mandated by Best Pharmaceuticals for Children Act: Summary of Committee Feedback and Options for Improvement, Dr. Solomon Iyasu, MD, MPH (PPT) (PDF)

Question fo the Committee (PPT) (PDF)