Food and Drug
Peripheral and Central Nervous System Drugs Advisory
May 17, 2006
Novartis Pharmaceutical Corp.
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.
NDA 20-823; SE1-016 Exelon ® (rivastigmine
tartrate) capsules (pdf
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.
Background Document (pdf)
FDA Clinical Review (pdf)
3. Statistical Review (pdf)