Drug Development

U.S. FDA grants fast track designation for esterase inhibitor for hereditary angioedema

Published in Drug Week, January 27th, 2006

Lev Pharmaceuticals, Inc. (LEVP.OB) announced that its investigational product C1-esterase inhibitor (C1-INH) has been granted fast track status by the U.S. Food and Drug Administration (FDA) for the treatment of hereditary angioedema (HAE).

The fast track programs of the FDA are designed to facilitate development and expedited review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Compounds designated with fast track status are eligible for accelerated FDA review and early submission of portions of the associated biologics license application for marketing...

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 Drug Week

Source: Drug Week (2006-01-27)

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