Food and Drug Administration

Pediatric Advisory Committee

September 15, 2004

Briefing Information

Overview Memorandum From Dr. Dianne Murphy, MD (HTM) (PDF) (Word)

Label: Advair Diskus® 100/50, Advair Diskus® 250/50, Advair Diskus® 500/50 Combination of of Fluticasone Propionate and Salmeterol Xinafoate For Oral Inhalation Only (PDF)

Fosamax® (Alendronate Sodium) Clinical Pharmacology and Biopharmaceutics Review (PDF)

Label: Fosamax® (Alendronate Sodium) Tablets and Oral Solution (PDF)

Fosamax® Medical Review (PDF)

Best Pharmaceuticals for Children Act (PDF)

Label: Cutivate® (Fluticasoe Propionate Ointment) For Dermatologic Use Only--Note for Ophthalmic Use (PDF)

Label: Clarinex® (Desloratadine) Tablets, Reditabs® Tablets (PDF)

Label: Flonase® (Fluticasone Propionate) Nasal Spray, 50 mcg (PDF)

Clinical Summary of Flonase® Nasal Spray, 50 mcg (PDF)

Label: Flovent® 44 mcg, Flovent® 110 mcg, Flovent® 220 mcg Inhalation Aerosol For Oral Inhalation Only (PDF)

Clinical Pharmacology and Bipharmaceutics Summary of Flovent (PDF)

Clinical Summary of Flovent® Inhalation Aerosol (PDF)

Clinical Pharmacology and Biopharmaceutics Review of Fludara (PDF)

Clinical Review of Fludarabine Phosphate (PDF)

Label: Fludara® (Fludarabine Phosphate) for Injection for Intravenous Use Only (PDF)

Pediatric Advisory Committee Pre-Publish Notice of Meeting (PDF)

Guidance for Industry: Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteriods on Growth in Children (PDF)

NAEPP Expert Panel Report -- Guidelines for the Diagnosis and Management of Asthma-Update on Selected Topics 2002 (PDF)

BPCA Summary of Ocuflox (Ofloxacin Ophthalmic Solution) 0.3% (PDF)

Label: Ocuflox® (Ofloxacin Ophthalmic Solution) 0.3% (PDF)

Clinical Team Leader Review Memorandum on Pulmicort® Respules™ (Budesonide Inhalation Suspension) (PDF)

Pulmicort Respules (Budesonide Inhalation Suspension) 0.25 mg and 0.5 mg (PDF)

Pulmicort Turbuhaler 200 mcg (Budesonide Inhalation Powder) For Oral Inhalation Only (PDF)

Label: Rhinocort Aqua (Budesonide) Nasal Spray 32 mcg For Intranasal Only (PDF)