Dockets:

Food and Drug Administration

Pediatric Advisory Committee

November 27-28, 2007

BRIEFING INFORMATION

Sponsors

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.

Hoffmann-La Roche Inc. (pdf)

Glasosmithkline (GSK) (pdf)

FDA

Disclaimer

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.

Cover Memo Murphy (pdf)

Tamiflu Background Summary (pdf)

Tamiflu Analysis of Health Claims Database Studies (pdf)

Tamiflu Addendum-Comment on Neuropsych Events (pdf)

Tamiflu Adverse Event Review 2007 (pdf)

Tamiflu Use Review 2007 (pdf)

Tamiflu BPCA Clinical Summary 2004 (pdf)

Tamiflu BPCA Clinical Pharm 2004 (pdf)

Okabe et al., 2000*

Morishima et al., 2002*

Newland et al., 2007*

Amantidine Label 2007 (pdf)

Relenza Label 2007 (pdf)

Rimantidine Label 2007 (pdf)

Tamiflu Label 2007 (pdf)

Salmeterol BPCA Clinical Review 2005 (pdf)

Salmeterol BPCA Summary 2005 (pdf)

Public Correspondence Letter (pdf)

Pulmonary-Allergy Drugs Advisory Committee Minutes (pdf)

Salmeterol Adverse Event Review (pdf)

Salmeterol Use Review (pdf)

Salpeter et al., 2006*

Salmeterol Label (pdf)

Modafinil BPCA Clinical Summary 2006 (pdf)

Modafinil Psychiatric Adverse Events Review 2006 (pdf)

Modafinil ADHD Pediatric Advisory Committee Slides 2006 (pdf)

Modafinil Medwatch Report 2007 (pdf)

Modafinil Adverse Event Review (pdf)

Modafinil Use Review (pdf)

Modafinil Dear Healthcare Provider Letter (pdf)

Modafinil Label (pdf)

Brinzolamide BPCA Clinical Summary (pdf)

Brinzolamide Adverse Event Review (pdf)

Brinzolamide Use Review (pdf)

Brinzolamide Label (pdf)

Levobetaxolol BPCA Clinical Summary (pdf)

Levobetaxolol Adverse Event Review (pdf)

Levobetaxolol Use Review (pdf)

Levobetaxolol Package Insert (pdf)

Levobetaxolol Label (pdf)

Emtricitabine BPCA Clinical Summary (pdf)

Emtricitabine BPCA Medical Summary (pdf)

Emtricitabine Adverse Event Review (pdf)

Emtricitabine Use Review (pdf)

Emtricitabine Label (pdf)

Imatinab Mesylate BPCA Clinical Summary (pdf)

Imatinab Mesylate BPCA Clinical Pharm (pdf)

Imatinab Mesylate Adverse Event Review (pdf)

Imatinab Mesylate Use Review (pdf)

Imatinab Mesylate Label (pdf)

* Copyrighted Material can be viewed in the Dockets Management Public Reading Room, 5630 Fishers Lane, Room 1061, Rockville, MD