logo
Share SHARE
FONT-SIZE Plus   Neg

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

Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) 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
Walt Disney Co. (DIS) is reportedly in talks to buy a stake in Major League Baseball Advanced Media. According to LA Times, citing people with knowledge of the matter, Disney is seeking to acquire one-third interest in the MLB.com, which develops and manages the league's digital products. The deal... Postal Savings Bank of China, one of the biggest banks in China, seeks to raise about $8 billion in an initial public offering, which could be the biggest IPO of the year. Postal Savings Bank of China plans to list its stock in the Hong Kong stock exchange. According to reports, the Postal Savings... Sporting goods retailer Dick's Sporting Goods, Inc. has emerged as the successful bidder in the bankruptcy auction for its former rival Sports Authority Holding Inc.'s intellectual property assets and the right to acquire 31 store leases.
comments powered by Disqus
Follow RTT