Food and Drug Administration

Pediatric Advisory Committee

March 22, 2006

Briefing Information

Letter to Committee Members - Overview (pdf)

Clofarabine (Clolar)

One-Year Post-Pediatric Exclusivity Post-marketing Adverse Event Review - Clofarabine Safety Review (NDA 21-673) (pdf)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Clofarabine (Clolar) Injection Review (NDA 21-673) (pdf)

Updated - Clinical Pharmacology and Biopharmaceutics Review - Clofarabine (Clolar) (NDA 21-673) (pdf)

Clinical Review for NDA 21-763 - Executive Summary (pdf)

Clolar for Intravenous Infusion - Clofarabine Final Draft Label (pdf)

Irbesartan (Avapro)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Avapro (irbesartan) (NDA 20-757) (pdf)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review: Drug Use Data - Avapro (irbesartan) (NDA 20-757) (pdf)

Clinical Review - Avapro (irbesartan) - Pediatric efficacy supplement (pdf)

Clinical Pharmacology and Biopharmaceutics Review Avapro (irbesartan) (NDA 20-757) (pdf)

Avapro (irbesartan) Tablets - Label (pdf)

Sibutramine (Meridia)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Sibutramine (Meridia) (NDA 20-632) (pdf)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review: Drug Use Data Sibutramine (Meridia) Capsule (NDA 20-632) (pdf)

Clinical Review for NDA 20-632 - Executive Summary -Sibutramine (Meridia) (pdf)

Clinical Pharmacology and Biopharmaceutics Review - Sibutramine (Meridia) Capsule (NDA 20-632) (pdf)

Meridia (sibutramine hydrochloride monhydrate) Capsules - Label (pdf)

FDA August 9, 2005 Response to Meridia Citizen Petition (pdf)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (Adderall XR)

Adverse Events Reported with Immediate-release Mixed Amphetamine Salt Products During the Adderall XR 1-year Post-pediatric Exclusivity Period - Adderall (NDA: 11-522) (pdf)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review - Adderall XR (NDA: N 21-303) (pdf)

One Year Post-Pediatric Exclusivity Postmarketing Adverse Event Review: Drug Utilization Data - Adderall XR) (NDA: 21-303) (pdf)

Clinical Pharmacology and Biopharmaceutics Review - Mixed Salts of Amphetamine (Adderall XR) (NDA: 21-303) (pdf)

Clinical Pharmacology and Biopharmaceutics Review - Mixed Salts of a Single Amphetamine Product (Adderall XR) (pdf)

Adderall CII (mixed Salt) - Label (pdf)

ADHD Medications

Summary of Psychiatric and Neurological Adverse Events from June 2005 1-year Post Pediatric Exclusivity Reviews of Concerta and Other Methylphenidate Products (pdf)

Psychiatric Adverse Events in Clinical Trials of Drugs for ADHD (pdf)

Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Date (pdf)

References (pdf)

Overview of the New Content and Format Requirements for Prescription Drug Labeling (ppt) (pdf)

Considerations for the Use of Risk Minimization Action Plans - FDA Draft Guidance and Experience, Anne Trontell, M.D., M.P.H., FDA (ppt) (pdf)

ADHD Drug Labels (pdf)

ADHA Labeling Regarding Cardiovascular Events (pdf)

Studying Cardiovascular Risk with Drug Treatments of ADHD, Kate Gelperin, M.D., M.P.H., FDA (ppt) (pdf)

Postmarketing Safety Review of Sudden Deaths during Treatment with Drugs used to Treat ADHD (pdf)

Review of AERS Data for Marketed Safety Experience during Stimulant Thereapy: death, sudden death, cardiovascular SAEs (including stroke) (pdf)

McNeil Consumer & Specialty Pharmaceuticals

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.

CONCERTA Extended-release Tablets -Briefing Document - (pdf)

Eli Lilly and Company

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.

Lilly Executive Summary: Strattera (NDA 21-411) (atomoxetine hydrochloride) (pdf)

Lilly Attachment 1: Meta-analysis of Suicide-related Events in Atomoxetine-treated Patients (pdf)

Lilly Attachment 2: Meta-analysis of Aggression or Hostility Events in Atomoxetine Pediatric Trials (pdf)

Lilly Attachment 3: Atomoxetine Treatment for Pediatric Patients with ADHD and Comorbid Anxiety (pdf)

Lilly Attachment 4: A Study of Atomoxetine in Adolescents with ADHD and Major Depressive Disorder (pdf)

Lilly Attachment 5: Improvement of ADHD by Atomoxetine in Children with Tic Disorders (pdf)

Lilly Attachment 6: Atomoxetine Treatment in Children and Adolescents with ADHD and Comorbid Tic Disorders, A. J. Allen, MD, PhD et al, AAN Enterprises, Inc., pp. 1941-1949

Additional Material Added March 20, 2006

Eli Lilly and Company

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.

Briefing Document Addendum (pdf )

Limitations in Determining Spontaneous Adverse Event Reporting Rates and Comparing Atomoxetine to other ADHD Medications (pdf)

Abuse Liability Assessment of Atomoxetine in a Drug-abusing Population (pdf)

Bibliography of References (pdf)