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)