Food and Drug Administration

Pediatric Advisory Committee

June 29, 2005

Briefing Information

Briefing Memorandum Dated June 24, 2005 From Dianne Murphy, MD, FDA (PDF)

Pediatric Market Exclusivity Incentive Program and Process (PDF)

The PAC's Role in Adverse Event report Review (PDF)

Section 17 of BPCA (PDF)

FDA Statement on Concerta and Methylphenidate for the June 30 PAC (PDF)

1-Year Post-Pediatirc Exclusivity Postmarketing Adverse Event Review - ORTHO TRI-CYCLEN® & ORTHO TRI-CYCLEN® (PDF)

Ortho Tri-cyclen Clinical Review - Use Cleared(PDF)

Ortho Tri-cyclen Clinical Review (PDF)

Clinical Pharmacology and Biopharmaceutics Review - Medical (PDF)

Ortho Tri-cyclen Clinical Parmacology (PDF)

Physicians Package Insert, FDA (PDF)

1-Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Detrol® and Detrol LA® (PDF)

Debrol Use Cleared (PDF)

BPAC Clinical Review - Detrol Medical (PDF)

Detrol Clinical Pharmacology and Biopharmaceutics Review (PDF)

Detrol Label, FDA (PDF)

Detrol LA Label, FDA (PDF)

1-Year Post Pediatric Exclusivity Postmarketing Adverse Events Review - Ciprofloxacin (PDF)

Cipro® Use Cleared (PDF)

Cipro® Medical (PDF)

Cipro® Clinical Pharmacology and Biopharmaceutics (PDF)

Cipro® Label Tablets and Oral Suspension (PDF)

Cipro® I.V. Label Injection (PDF)

1-Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Zemplar™ (PDF)

Zemplar Use Cleared (PDF)

Zemplar Clinical Review - Medical (PDF)

Zemplar Label Fliptop Vial (PDF)

1-Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Zolmitriptan (PDF)

Zomig® Use Cleared (PDF)

Zomig® Clinical Review - Medical (PDF)

Zomig® Summary of Clinical Pharmacology and Biopharmaceutics Findings (PDF)

Zomig Label Tablets and Orally Disintegrating Tablets, FDA (PDF)

1-Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Trusopt® (PDF)

Trusopt® Use Cleared (PDF)

Truspt Medical Officer's Review (PDF)

Trusopt Label Sterile Ophthalmic Solution, FDA (PDF)

1-Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Arava® (PDF)

Arava® Use Cleared (PDF)

Arava® Clinical Review - Medical (PDF)

Arava® Clinical Pharmacology and Biopharmacuetics Review (PDF)

Arava® Tablets Label, FDA (PDF)