Penwest Pharmaceuticals Co.

Primary endpoints met in PW2101 hypertension study

Published in Pharma Law Weekly, April 20th, 2004

Penwest Pharmaceuticals Co. (PPCO) announced that primary end points were met in their efficacy study for PW2101, the company's product for the treatment of hypertension, and the clinical development program is now complete.

Penwest plans to submit a 505(b)2 New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the end of 2004, seeking approval for the higher strengths of the product.

The company intends to complete some additional work to support a manufacturing site change prior to submission. It is currently seeking a marketing partner for this product.

This pivotal study was a randomized, double-blind,...

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 Pharma Law Weekly

Source: Pharma Law Weekly (2004-04-20)

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