Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee

December 2, 2005

The committee will discuss new drug application (NDA) 21-514, proposed trade name METHYPATCH (Methylphenidate) Tdp, 
(Methylphenidate Transdermal System), Noven Pharmaceuticals, proposed indication for the treatment of attention deficit hyperactivity disorder (ADHD).

 

Briefing Information

Noven Pharmaceuticals, Inc.

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.

MTS Briefing Document

Appendix 1: Pharmacokinetics/Pharmacodynamics Summary

Appendix 2: Efficacy Summary

Appendix 3: Safety Summary

Appendix 4: Integrated Summary of Risks and Benefits

 

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.

Tab 1 Memo From Thomas P. Laughren, M.D., Director, Division of Psychiatry Products

Tab 2 Clinical Review

Tab 3 Controlled Substances Staff

Tab 4 Statistical Review