MINUTES OF THE
PEDIATRIC ADVISORY COMMITTEE
Advisory Committee Conference Room, Room 1066
Thursday,
November 16th, 2006
The meeting was convened at approximately 8:15 a.m.
Members Present (voting) for November 16th,
2006
Avital Cnaan, Ph.D., M.S.
Robert S. Daum, M.D.
Leon Dure, M.D.
Melissa Maria Hudson, M.D.
Keith Kocis, M.D., M.S.
John W. M. Moore, M.D., M.P.H.
Thomas B. Newman, M.D., M.P.H.
Pediatric Advisory Committee Pediatric
Health Organization Representative
Richard L. Gorman, M.D.
Pediatric Advisory Committee Industry
Representative
Elizabeth A.
Garofalo, M.D.
Executive Secretary
Carlos Peña, Ph.D., M.S.
FDA Participants
Debra Birnkrant, M.D.
Marc Cavaillé-Coll, M.D., Ph.D.
Martin Cohen, M.D.
Felicia Collins, M.D., M.P.H., FAAP
Eileen Craig, M.D.
Linda Forsyth, M.D.
Mark Hirsch, M.D.
Rosemary Johann-Liang, M.D., FAAP
Lisa Jones, M.D.
Russell Katz, M.D.
Joyce Korvick, M.D.
Thomas Laughren, M.D.
Linda Lewis, M.D.
Iris Masucci, PharmD, BCPS
Lisa Mathis, M.D.
Evelyn
Mentari, M.D., M.S.
Robert Misbin, M.D.
Andrew Mosholder, M.D., M.P.H.
Dianne Murphy, M.D., FAAP
Andreas Pikis, M.D.
Alan Shapiro, M.D., Ph.D., FAAP
Jeffrey Siegel, M.D.
Alfred Sorbello, D.O.
Jean Temeck, M.D.
Hui-Hsing Wong, M.D.
Joanna Zawadzki, M.D., FACP, FACE
Voting Consultants
Larry Sasich,
Pharm.D., M.P.H., FASHP (Acting Consumer
Representative)
Geoffrey L. Rosenthal, M.D., Ph.D.
Open Public Hearing Speakers
None
Presentations
Pediatric Advisory Committee: Overview of Role and Evolution of Process
Dianne Murphy, M.D., FAAP, Director, Office of Pediatric Therapeutics, OC
Committee
Role in BPCA Safety Reviews
Rosemary Johann-Liang, MD, FAAP, Deputy Director, Division of Drug Risk Evaluation, CDER
One
Year Post-Exclusivity Adverse Event Review: Zyvox (Linezolid)
Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER
One
Year Post-Exclusivity Adverse Event Review: Avandia (Rosiglitazone)
Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER
One
Year Post-Exclusivity Adverse Event Review: Zofran (Ondansetron)
Felicia Collins, MD, MPH, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER
One
Year Post-Exclusivity Adverse Event Review: Celexa (Citalopram) – Safety Update
Lisa Mathis, MD
Review
Update: QT Prolongation With Citalopram and Escitalopram
Lisa Jones, MD, Medical Officer, Division of Psychiatry Products, CDER
One
Year Post-Exclusivity Adverse Event Review: Trileptal (Oxcarbazepine)
Felicia Collins, MD, MPH, FAAP
Suicidality
and Antiepileptic Drugs:Status of Clinical Trial Data Analysis
Evelyn Mentari, MD, MS, Medical Officer, Division of Neurology Products, CDER
Tamiflu
(Oseltamivir) – Safety Update
Rosemary Johann-Liang, MD, FAAP, Andrew Mosholder, MD, MPH, Epidemiologist, Division of Drug Risk Evaluation, CDER
Update
on Current FDA Labeling Initiatives
Iris Masucci, PharmD, BCPS, CDER
One Year Post-Exclusivity Adverse Event Review: Norvir (Ritonavir)
Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER
One Year Post-Exclusivity Adverse Event Review: Rapamune
(Sirolimus)
Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER
Abbreviated
Presentations and Updates to Committee: Invanz (Ertapenem)
Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Gemzar (Gemcitabine)
Alan Shapiro, MD, PhD, FAAP, Medical Officer, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Amaryl (Glimepiride)
Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Novolog (Insulin Aspart Recombinant)
Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Mobic (Meloxicam)
Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Ditropan (Oxbutynin) – Safety Update
Lisa Mathis, MD, Director, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Lipitor (Atorvastatin) – Safety Update
Jean Temeck, MD, Medical
Officer, Pediatric and Maternal Health Staff, CDER
Abbreviated Presentations and Updates to Committee: Zocor (Simvastatin) – Safety Update
Jean Temeck, MD, Medical
Officer, Pediatric and Maternal Health Staff, CDER
Sponsor Presentations
None
Summary of Committee Discussions and
Recommendations
One
Year Post-Exclusivity Adverse Event Review: Zyvox (Linezolid)
Committee Recommendations –
Committee Vote –
One
Year Post-Exclusivity Adverse Event Review: Celexa (Citalopram) – Safety Update
Committee Recommendations –
Committee Vote –
One
Year Post-Exclusivity Adverse Event Review: Trileptal (Oxcarbazepine)
Committee Recommendations –
Committee Vote –
Tamiflu
(Oseltamivir) – Safety Update
Committee Recommendations –
· One Committee member expressed concern about the label recommending against treatment of infants less than one year of age due to their high mortality from influenza, but no vote was taken concerning this issue.
Committee Vote –
One
Year Post-Exclusivity Adverse Event Review: Avandia (Rosiglitazone)
Committee Recommendations –
Committee Vote –
One
Year Post-Exclusivity Adverse Event Review: Zofran (Ondansetron)
Committee Recommendations –
Committee Vote –
One Year Post-Exclusivity Adverse Event Review: Norvir (Ritonavir)
Committee Recommendations –
Committee Vote –
One Year Post-Exclusivity Adverse Event Review: Rapamune
(Sirolimus)
Committee Recommendations –
Committee Vote –
One Year Post-Exclusivity Adverse Event Review: Invanz
(Ertapenem)
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to
Committee: Gemzar (Gemcitabine)
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to Committee: Amaryl (Glimepiride)
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to Committee: Novolog (Insulin Aspart Recombinant)
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to Committee: Mobic (Meloxicam)
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to Committee: Ditropan (Oxbutynin) – Safety Update
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to Committee: Lipitor (Atorvastatin) – Safety Update
Committee Recommendations –
Committee Vote –
Abbreviated Presentations and Updates to Committee: Zocor (Simvastatin) – Safety Update
Committee Recommendations –
Committee Vote –
Additional Committee Recommendations –
The meeting adjourned at approximately 4:15 p.m.
Please see transcript for details
I certify that I attended the November 16, 2006 meeting of the Pediatric Advisory Committee and that these minutes accurately reflect what transpired.
//S// .
Carlos Peña, Ph.D., M.S.
Executive Secretary
//S// .
Robert Ward, M.D.
Acting Chair