FDA Briefing Notes for September SSRI Hearing

[Guest guest]

** Note **

Click on the link to access all information.

http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm

Food and Drug Administration - Joint Meeting of the Psychopharmacologic

Drugs Advisory Committee and Pediatric Advisory Committee

September 13 - 14, 2004

Briefing Information

Food and Drug Administration Background Information

• August 17, 2004 to Psychopharmacologic Drugs Advisory Committee

Members/Consultants and Pediatric Advisory Committee Consultants from Anuja

M. Patel, MPH, Center for Drug Evaluation and Research, FDA pdf

• August 16, 2004 Memorandum to Members of the PDAC and Peds AC Committees:

Overview for September 13 & 14, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Drugs Advisory Committee (Peds AC)

pdf htm Word

• January 5, 2004 Memorandum to Members of PDAC and Peds AC: Background

Comments for February 2, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective

Drugs Advisory Committee (Peds AC) pdf

• Summary Minutes of the Psychopharmacologic Drugs Advisory Committee

meeting and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory

Committee, February 2, 2004 pdf htm Word

• Antidepressant Use and Risk of Suicide Attempt in Adolescents with Major

Depressive Disorder; J. Valuck, PhD, Anne M Libby, PhD, n R

Sills, MD, MPH, is A Giese MD, R , MS, University of

Colorado

• Bibliography htm

• Review and Evaluation of Clinical Data; Placebo-Controlled Antidepressant

Studies in Pediatric Patients, M Dubitsky, MD, Center for Drug

Evaluation and Research, FDA pdf

• Report of the Audit of the Columbia Suicidality Classification

Methodology, Iyasu, MD MPH, Center for Drug Evaluation and Research,

FDA pdf htm Word

• Review and Evaluation of Clinical Data, Tarek A Hammad, MD, PhD, MSc, MS,

Center for Drug Evaluation and Research, FDA pdf

• Analysis of Original Pediatric Suicidality Data, Comparison of Initial

Analysis, Results and Classified Cases Analysis, Mosholder, MD,

Center for Drug Evaluation and Research, FDA

& #61607; August 16, 2004 pdf

& #61607; March 15, 2004 pdf

• June 19, 2003 FDA Talk Paper, FDA Statement Regarding the Anti-Depressant

Paxil for Pediatric Population htm

• October 27, 2003, FDA Public Health Advisory, Reports of Suicidality in

Pediatric Patients Being Treated with Antidepressant Medications for Major

Depressive Disorder (MDD) htm

• October 27, 2003, FDA Talk Paper, FDA Issues Public Health Advisory

Entitled: Reports Of Suicidality in Pediatric Patients Being Treated with

Antidepressant Medications for Major Depressive Disorder (MDD) htm

• March 22, 2004, FDA Talk Paper, FDA Issues Public Health Advisory on

Cautions for Use of Antidepressants in Adults and Children htm

• March 22, 2004 Background Information on the Suicidality Classification

Project htm

• March 22, 2004, FDA Public Health Advisory, Worsening Depression and

Suicidality in Patients Being Treated with Antidepressant Medications htm

• March 22, 2004, Questions and Answers on Antidepressant Use in Children,

Adolescents, and Adults htm

• Product Labeling for Antidepressants

& #61607; Wellbutrin (bupropion hydrochloride) Tablets pdf

& #61607; Celexa (citalopram hydrobromide) Tablets/Oral Solution pdf

& #61607; Lexapro (escitalopram oxalate) Tablets/Oral Solution pdf

& #61607; Effexor (venlafaxine hydrochloride) Tablets pdf

& #61607; Paxil (paroxetine hydrochloride) Tablets and Oral Suspension pdf

& #61607; Serzone (nefazodone hydrochloride) Tablets pdf

& #61607; Remeron (mirtazapine) Tablets pdf

Eli Lilly and Company Background Information

Prozac (Fluoxetine Hydrochloride)

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Form 356h pdf

& #61607; Table of Contents pdf

& #61607; Attachment 1 Principles of Medical Research pdf htm Word

& #61607; Attachment 2 Clinical Trial Registry pdf htm Word

Pfizer Global Pharmaceuticals Background Information

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Table of Contents pdf

& #61607; July 26, 2004 Letter to FDA from Pfizer Global Research &

Development pdf

& #61607; February 19, 2004 Letter to FDA from Healy, MD pdf

[Guest guest]

** Note **

Click on the link to access all information.

http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm

Food and Drug Administration - Joint Meeting of the Psychopharmacologic

Drugs Advisory Committee and Pediatric Advisory Committee

September 13 - 14, 2004

Briefing Information

Food and Drug Administration Background Information

• August 17, 2004 to Psychopharmacologic Drugs Advisory Committee

Members/Consultants and Pediatric Advisory Committee Consultants from Anuja

M. Patel, MPH, Center for Drug Evaluation and Research, FDA pdf

• August 16, 2004 Memorandum to Members of the PDAC and Peds AC Committees:

Overview for September 13 & 14, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Drugs Advisory Committee (Peds AC)

pdf htm Word

• January 5, 2004 Memorandum to Members of PDAC and Peds AC: Background

Comments for February 2, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective

Drugs Advisory Committee (Peds AC) pdf

• Summary Minutes of the Psychopharmacologic Drugs Advisory Committee

meeting and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory

Committee, February 2, 2004 pdf htm Word

• Antidepressant Use and Risk of Suicide Attempt in Adolescents with Major

Depressive Disorder; J. Valuck, PhD, Anne M Libby, PhD, n R

Sills, MD, MPH, is A Giese MD, R , MS, University of

Colorado

• Bibliography htm

• Review and Evaluation of Clinical Data; Placebo-Controlled Antidepressant

Studies in Pediatric Patients, M Dubitsky, MD, Center for Drug

Evaluation and Research, FDA pdf

• Report of the Audit of the Columbia Suicidality Classification

Methodology, Iyasu, MD MPH, Center for Drug Evaluation and Research,

FDA pdf htm Word

• Review and Evaluation of Clinical Data, Tarek A Hammad, MD, PhD, MSc, MS,

Center for Drug Evaluation and Research, FDA pdf

• Analysis of Original Pediatric Suicidality Data, Comparison of Initial

Analysis, Results and Classified Cases Analysis, Mosholder, MD,

Center for Drug Evaluation and Research, FDA

& #61607; August 16, 2004 pdf

& #61607; March 15, 2004 pdf

• June 19, 2003 FDA Talk Paper, FDA Statement Regarding the Anti-Depressant

Paxil for Pediatric Population htm

• October 27, 2003, FDA Public Health Advisory, Reports of Suicidality in

Pediatric Patients Being Treated with Antidepressant Medications for Major

Depressive Disorder (MDD) htm

• October 27, 2003, FDA Talk Paper, FDA Issues Public Health Advisory

Entitled: Reports Of Suicidality in Pediatric Patients Being Treated with

Antidepressant Medications for Major Depressive Disorder (MDD) htm

• March 22, 2004, FDA Talk Paper, FDA Issues Public Health Advisory on

Cautions for Use of Antidepressants in Adults and Children htm

• March 22, 2004 Background Information on the Suicidality Classification

Project htm

• March 22, 2004, FDA Public Health Advisory, Worsening Depression and

Suicidality in Patients Being Treated with Antidepressant Medications htm

• March 22, 2004, Questions and Answers on Antidepressant Use in Children,

Adolescents, and Adults htm

• Product Labeling for Antidepressants

& #61607; Wellbutrin (bupropion hydrochloride) Tablets pdf

& #61607; Celexa (citalopram hydrobromide) Tablets/Oral Solution pdf

& #61607; Lexapro (escitalopram oxalate) Tablets/Oral Solution pdf

& #61607; Effexor (venlafaxine hydrochloride) Tablets pdf

& #61607; Paxil (paroxetine hydrochloride) Tablets and Oral Suspension pdf

& #61607; Serzone (nefazodone hydrochloride) Tablets pdf

& #61607; Remeron (mirtazapine) Tablets pdf

Eli Lilly and Company Background Information

Prozac (Fluoxetine Hydrochloride)

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Form 356h pdf

& #61607; Table of Contents pdf

& #61607; Attachment 1 Principles of Medical Research pdf htm Word

& #61607; Attachment 2 Clinical Trial Registry pdf htm Word

Pfizer Global Pharmaceuticals Background Information

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Table of Contents pdf

& #61607; July 26, 2004 Letter to FDA from Pfizer Global Research &

Development pdf

& #61607; February 19, 2004 Letter to FDA from Healy, MD pdf

[Guest guest]

** Note **

Click on the link to access all information.

http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm

Food and Drug Administration - Joint Meeting of the Psychopharmacologic

Drugs Advisory Committee and Pediatric Advisory Committee

September 13 - 14, 2004

Briefing Information

Food and Drug Administration Background Information

• August 17, 2004 to Psychopharmacologic Drugs Advisory Committee

Members/Consultants and Pediatric Advisory Committee Consultants from Anuja

M. Patel, MPH, Center for Drug Evaluation and Research, FDA pdf

• August 16, 2004 Memorandum to Members of the PDAC and Peds AC Committees:

Overview for September 13 & 14, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Drugs Advisory Committee (Peds AC)

pdf htm Word

• January 5, 2004 Memorandum to Members of PDAC and Peds AC: Background

Comments for February 2, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective

Drugs Advisory Committee (Peds AC) pdf

• Summary Minutes of the Psychopharmacologic Drugs Advisory Committee

meeting and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory

Committee, February 2, 2004 pdf htm Word

• Antidepressant Use and Risk of Suicide Attempt in Adolescents with Major

Depressive Disorder; J. Valuck, PhD, Anne M Libby, PhD, n R

Sills, MD, MPH, is A Giese MD, R , MS, University of

Colorado

• Bibliography htm

• Review and Evaluation of Clinical Data; Placebo-Controlled Antidepressant

Studies in Pediatric Patients, M Dubitsky, MD, Center for Drug

Evaluation and Research, FDA pdf

• Report of the Audit of the Columbia Suicidality Classification

Methodology, Iyasu, MD MPH, Center for Drug Evaluation and Research,

FDA pdf htm Word

• Review and Evaluation of Clinical Data, Tarek A Hammad, MD, PhD, MSc, MS,

Center for Drug Evaluation and Research, FDA pdf

• Analysis of Original Pediatric Suicidality Data, Comparison of Initial

Analysis, Results and Classified Cases Analysis, Mosholder, MD,

Center for Drug Evaluation and Research, FDA

& #61607; August 16, 2004 pdf

& #61607; March 15, 2004 pdf

• June 19, 2003 FDA Talk Paper, FDA Statement Regarding the Anti-Depressant

Paxil for Pediatric Population htm

• October 27, 2003, FDA Public Health Advisory, Reports of Suicidality in

Pediatric Patients Being Treated with Antidepressant Medications for Major

Depressive Disorder (MDD) htm

• October 27, 2003, FDA Talk Paper, FDA Issues Public Health Advisory

Entitled: Reports Of Suicidality in Pediatric Patients Being Treated with

Antidepressant Medications for Major Depressive Disorder (MDD) htm

• March 22, 2004, FDA Talk Paper, FDA Issues Public Health Advisory on

Cautions for Use of Antidepressants in Adults and Children htm

• March 22, 2004 Background Information on the Suicidality Classification

Project htm

• March 22, 2004, FDA Public Health Advisory, Worsening Depression and

Suicidality in Patients Being Treated with Antidepressant Medications htm

• March 22, 2004, Questions and Answers on Antidepressant Use in Children,

Adolescents, and Adults htm

• Product Labeling for Antidepressants

& #61607; Wellbutrin (bupropion hydrochloride) Tablets pdf

& #61607; Celexa (citalopram hydrobromide) Tablets/Oral Solution pdf

& #61607; Lexapro (escitalopram oxalate) Tablets/Oral Solution pdf

& #61607; Effexor (venlafaxine hydrochloride) Tablets pdf

& #61607; Paxil (paroxetine hydrochloride) Tablets and Oral Suspension pdf

& #61607; Serzone (nefazodone hydrochloride) Tablets pdf

& #61607; Remeron (mirtazapine) Tablets pdf

Eli Lilly and Company Background Information

Prozac (Fluoxetine Hydrochloride)

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Form 356h pdf

& #61607; Table of Contents pdf

& #61607; Attachment 1 Principles of Medical Research pdf htm Word

& #61607; Attachment 2 Clinical Trial Registry pdf htm Word

Pfizer Global Pharmaceuticals Background Information

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Table of Contents pdf

& #61607; July 26, 2004 Letter to FDA from Pfizer Global Research &

Development pdf

& #61607; February 19, 2004 Letter to FDA from Healy, MD pdf

[Guest guest]

** Note **

Click on the link to access all information.

http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm

Food and Drug Administration - Joint Meeting of the Psychopharmacologic

Drugs Advisory Committee and Pediatric Advisory Committee

September 13 - 14, 2004

Briefing Information

Food and Drug Administration Background Information

• August 17, 2004 to Psychopharmacologic Drugs Advisory Committee

Members/Consultants and Pediatric Advisory Committee Consultants from Anuja

M. Patel, MPH, Center for Drug Evaluation and Research, FDA pdf

• August 16, 2004 Memorandum to Members of the PDAC and Peds AC Committees:

Overview for September 13 & 14, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Drugs Advisory Committee (Peds AC)

pdf htm Word

• January 5, 2004 Memorandum to Members of PDAC and Peds AC: Background

Comments for February 2, 2004 Meeting of Psychopharmacological Drugs

Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective

Drugs Advisory Committee (Peds AC) pdf

• Summary Minutes of the Psychopharmacologic Drugs Advisory Committee

meeting and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory

Committee, February 2, 2004 pdf htm Word

• Antidepressant Use and Risk of Suicide Attempt in Adolescents with Major

Depressive Disorder; J. Valuck, PhD, Anne M Libby, PhD, n R

Sills, MD, MPH, is A Giese MD, R , MS, University of

Colorado

• Bibliography htm

• Review and Evaluation of Clinical Data; Placebo-Controlled Antidepressant

Studies in Pediatric Patients, M Dubitsky, MD, Center for Drug

Evaluation and Research, FDA pdf

• Report of the Audit of the Columbia Suicidality Classification

Methodology, Iyasu, MD MPH, Center for Drug Evaluation and Research,

FDA pdf htm Word

• Review and Evaluation of Clinical Data, Tarek A Hammad, MD, PhD, MSc, MS,

Center for Drug Evaluation and Research, FDA pdf

• Analysis of Original Pediatric Suicidality Data, Comparison of Initial

Analysis, Results and Classified Cases Analysis, Mosholder, MD,

Center for Drug Evaluation and Research, FDA

& #61607; August 16, 2004 pdf

& #61607; March 15, 2004 pdf

• June 19, 2003 FDA Talk Paper, FDA Statement Regarding the Anti-Depressant

Paxil for Pediatric Population htm

• October 27, 2003, FDA Public Health Advisory, Reports of Suicidality in

Pediatric Patients Being Treated with Antidepressant Medications for Major

Depressive Disorder (MDD) htm

• October 27, 2003, FDA Talk Paper, FDA Issues Public Health Advisory

Entitled: Reports Of Suicidality in Pediatric Patients Being Treated with

Antidepressant Medications for Major Depressive Disorder (MDD) htm

• March 22, 2004, FDA Talk Paper, FDA Issues Public Health Advisory on

Cautions for Use of Antidepressants in Adults and Children htm

• March 22, 2004 Background Information on the Suicidality Classification

Project htm

• March 22, 2004, FDA Public Health Advisory, Worsening Depression and

Suicidality in Patients Being Treated with Antidepressant Medications htm

• March 22, 2004, Questions and Answers on Antidepressant Use in Children,

Adolescents, and Adults htm

• Product Labeling for Antidepressants

& #61607; Wellbutrin (bupropion hydrochloride) Tablets pdf

& #61607; Celexa (citalopram hydrobromide) Tablets/Oral Solution pdf

& #61607; Lexapro (escitalopram oxalate) Tablets/Oral Solution pdf

& #61607; Effexor (venlafaxine hydrochloride) Tablets pdf

& #61607; Paxil (paroxetine hydrochloride) Tablets and Oral Suspension pdf

& #61607; Serzone (nefazodone hydrochloride) Tablets pdf

& #61607; Remeron (mirtazapine) Tablets pdf

Eli Lilly and Company Background Information

Prozac (Fluoxetine Hydrochloride)

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Form 356h pdf

& #61607; Table of Contents pdf

& #61607; Attachment 1 Principles of Medical Research pdf htm Word

& #61607; Attachment 2 Clinical Trial Registry pdf htm Word

Pfizer Global Pharmaceuticals Background Information

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

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 Information pdf htm Word

& #61607; Cover Letter pdf

& #61607; Table of Contents pdf

& #61607; July 26, 2004 Letter to FDA from Pfizer Global Research &

Development pdf

& #61607; February 19, 2004 Letter to FDA from Healy, MD pdf