Food
and Drug Administration
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.
Appendix 1: Pharmacokinetics/Pharmacodynamics 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