FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Up | AC Home Page

Food and Drug Administration

Pediatric Advisory Committee

November 16, 2006

Briefing Information


Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

Briefing Memo (pdf)

Linezolid Safety Review (pdf)
Linezolid Use Review (pdf)
Linezolid Clinical Summary (pdf)
Linezolid Clinical Pharm Summary (pdf)
Linezolid FDA Label (pdf)

Ritonavir Safety Review (pdf)
Ritonavir Use Review (pdf)
Ritonavir Clinical Summary (pdf)
Ritonavir Clinical Pharm Summary (pdf)
Ritonavir FDA Label (pdf)

Sirolimus Safety Review (pdf)
Sirolimus Safety Review Redacted (pdf)
Sirolimus Use Review (pdf)
Sirolimus Use Review Table (pdf)
Sirolimus Clinical Summary (pdf)
Sirolimus Clinical Pharm Summary (pdf)
Sirolimus FDA Label (pdf)

Rosiglitazone Safety Review Redacted (pdf)
Rosiglitazone Use Data (pdf)
Rosiglitazone Use Data Revised (pdf)
Rosiglitazone Clinical Summary (pdf)
Rosiglitazone Clinical Pharm Summary (pdf)
Rosiglitazone FDA Label (pdf)

Ondansetron Safety Review Redacted (pdf)
Ondansetron Use Data (pdf)
Ondansetron Use Data Revised (pdf)
Ondansetron Clinical Summary (pdf)
Ondansetron Clinical Pharm Summary (pdf)
Ondansetron FDA Label (pdf)

Oxcarbazepine AE Review (pdf)
Oxcarbazepine Use Data (pdf)
Oxcarbazepine Clinical Summary (pdf)
Oxcarbazepine Clinical Pharm Summary (pdf)
Oxcarbazepine FDA Label (pdf)

Citalopram AE Review 2003 (pdf)
Citalopram AE Review 2006 (pdf)
Citalopram Medical (pdf)
Citalopram Clinical Pharm (pdf)
Citalopram FDA Label (pdf)
Citalopram QT Guidance (pdf)

Tamiflu AE Review 2006 (pdf)
Tamiflu Medical (pdf)
Tamiflu Clinical Pharm (pdf)
KP Tamiflu FDA Label 12-2005 (pdf)
Tamiflu Package Insert 11-2006 (pdf) (New 11-13-2006)
Tamiflu Patient Product Information 11-2006 (pdf) (New 11-13-2006)

Ertapenem Safety Review (pdf)
Ertapenem Use Review (pdf)
Ertapenem Clinical Summary (pdf)
Ertapenem Clinical Pharm Summary (pdf)
Ertapenem FDA Label (pdf)

Gemcitabine Safety Review (pdf)
Gemcitabine Use Review (pdf)
Gemcitabine Clinical Summary (pdf)
KP Gemcitabine FDA Label (pdf)

Glimepiride Safety Review (pdf)
Glimepiride Use Review (pdf)
Glimepiride Clinical Summary (pdf)
Glimepiride Clinical Pharm Summary (pdf)
KP Glimepiride FDA Label (pdf)

Insulin AE Review 2006 (pdf)
Insulin Use Review (pdf)
Insulin Clinical Summary (pdf)
KP Insulin FDA Label (pdf)

Meloxicam AE Review 2006 (pdf)
Meloxicam Use Review (pdf)
Meloxicam Clinical Summary (pdf)
Meloxicam Clinical Pharm Summary (pdf)
KP Meloxicam FDA Label 2005 (pdf)

Oxybutynin AE Review (pdf)
Oxybutynin Clinical Review (pdf)
Oxybutynin Label (pdf)
Oxybutynin XL Label (pdf)

Atorvastatin AE Review 2006 Redacted (pdf)
KP Atorvastatin FDA Label (pdf)

Simvastin AE Review Redacted 2006 (pdf)
KP Simvastin Label 2005 (pdf)

Page last updated November 13, 2006 kkhorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management