Food and Drug Administration

Peripheral and Central Nervous System Drugs Advisory Committee

August 4, 2005

Background Information

•  FDA Memo to Advisory Committee; Eric Bastings, MD, June 20,2005

•  FDA Not Approvable Letter; Russell Katz, MD; May 28, 2004

•  FDA Division Director Memo: Action Memo for NDA 21-645, for the use of Myzan (Naproxen/Metoclopramide) Tablets in the acute treatment of migraine; May 27, 22004; Russell Katz, MD

•  FDA Clinical Team Leader Memo; Eric Bastings, MD, May 18, 2004

•  FDA Clinical Review; Kevin Prohaska, DO; April 13, 2004

•  FDA Statistical Review; Yeh-Fong Chen, PhD; May 10, 2004

•  FDA Pharmacology Team Leader Memo; Barry Rosloff, PhD, May 14, 2004

•  FDA ODS Postmarketing Safety Review; Mary Ross Southworth, PharmD, Safety Evaluator; May 5, 2005

•  FDA ODS Postmarketing Safety Review- Addendum to Previous Review ; Mary Ross Southworth, PharmD, Safety Evaluator; June 9, 2005

•  FDA DSRCS Review, Sigal Kaplan, PhD, BPharm; Metoclopramide: Drug Use Data Review (Myzan, NDA 21-645); June 10, 2005