Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Salix, Progenics Announce FDA Extension Of RELISTOR SNDA Goal Date To July 27

Salix Pharmaceuticals, Ltd. (SLXP: Quote) and Progenics Pharmaceuticals (PGNX: Quote) announced that the Food and Drug Administration, or FDA, has extended the Prescription Drug User Fee Act goal date for the Agency's review of the Supplemental New Drug Application, or sNDA, for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.

The FDA has notified Salix that it requires additional time for a full review of the submission and has extended the April 27, 2012 goal date by the standard extension period of three months. The extended user fee goal date is July 27, 2012. The extension requested no additional studies.

Click here to receive FREE breaking news email alerts for Salix Pharmaceuticals Ltd and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Micro-blogging site Twitter Inc said Tuesday after the markets closed that its second quarter loss widened from last year, hurt mainly by stock-based compensation expense, even as revenue more than doubled thanks to growth in advertising. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. US President Back Obama on Tuesday announced a new round of sanctions against Russia over Moscow's continued involvement in the ongoing conflict in Ukraine, hours after the European Union decided to expand its own sanctions imposed on Russia over the same issue. "Because we are closely coordinating our actions with Europe, the sanctions we are announcing today will have an even bigger bite. After showing a notable move to the upside in early trading on Tuesday, stocks showed a substantial downturn over the course of the session. Concerns about the impact of new sanctions against Russia weighed on the markets.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.