Food and Drug Administration

Pediatric Advisory Committee

June 30, 2005

Briefing Information

Memorandum Regarding Concerta Adverse Event Review, Kathleen Phelan, RPh, FDA (PDF)

Memorandum Regarding Adverse Events With Methylphenidate Products Other Than Concerta, Kathleen Phelan, RPh, FDA (PDF)

Memorandum Regarding Concerta® Use Granted, Laura Governale, PharmD, MBA, FDA (PDF)

Concerta Clinical Review, FDA (PDF)

Concerta Clinical Pharmacology/Biopharmaceutics Reveiw, FDA (PDF)

Concerta (methylphenidate HCI) Extended-Release Tablets, FDA (PDF)

Follow-up

The Commissioner's Finding (PDF)