logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
This footwear company outperformed in the latest first quarter, despite significant headwinds from a strong U.S. dollar, slowdown at the west coast ports and seasonably cold weather in certain key markets and less efficient operations than originally anticipated at the company's European distribution center. UK-based oil giant BP Plc. and French peer Total SA Tuesday reported lower profit for the first quarter, as oil prices declined sharply from the previous year. However, results reflected stronger overall refining environment. Hartford Financial reported a decline in first-quarter profit, despite growth in premiums, due mainly to the absence of gains recorded last year.
comments powered by Disqus
RELATED NEWS
Trade SLXP now with 
Follow RTT