Tardive Dyskinesia

Pharma company reports on MT-100 FDA meeting, Trexima NDA submission

Published in Medical Letter on the CDC and FDA, September 11th, 2005

POZEN Inc. (POZN) announced that the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous Systems Drugs Advisory Committee met recently to specifically address the risk of tardive dyskinesia, an involuntary neurological movement disorder associated with the use of metoclopramide hydrochloride, one of the components of MT 100.

The advisory committee voted that the potential, but unquantified, risk for tardive dyskinesia would outweigh the benefits, as defined by the FDA, of metoclopramide hydrochloride in combination with naproxen sodium. The company received a "not approvable" letter from the FDA in May 2004.

"Based on a...

Want to see the full article?

Purchase this article for only $3.00

We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.

Welcome to NewsRx!

Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA

Source: Medical Letter on the CDC and FDA (2005-09-11)

NewsRx is Social

Top Medical Newsletters

Awards

Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005

Facts & Stats

NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.

Google 2010 PageRank: #2 Among Top Health News and Media Publications
Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry