Respiratory Tract Infections

Complete response filed to FDA approvable letter for Ketek

Published in TB and Outbreaks Week, October 8th, 2002

Aventis announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a complete response to the agency's June 1, 2001, approvable letter for Ketek (telithromycin) tablets (800 mg oral dose once daily).

The FDA has advised the company that a target action date is expected within 6 months.

The filing includes data from a trial with more than 24,000 patients, which is the largest single comparative antibiotic trial ever conducted.

Last year, Aventis received an approvable letter for Ketek for the treatment of community-acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB) and acute...

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 TB and Outbreaks Week

Source: TB and Outbreaks Week (2002-10-08)

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