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
Automotive startup Divergent 3D said that a Chinese-led investment syndicate has agreed to commit up to $107 million in financing through a new investment round. Hong Kong-based investment holding company, O Luxe Holdings Limited, led the investment group, which includes Horizons Ventures, Shanghai Alliance Investment Limited and Altran Technologies. Apple Inc. has recently acquired Canada-based startup Vrvana, maker of the Totem augmented reality headset, TechCrunch reported. Both the companies reportedly declined to confirm news about the deal, which is reportedly worth $30 million. Shares of Thomas Cook Group Plc. were losing around 11 percent in the morning trading in London after the British tour operator reported Wednesday weak UK margins in its fiscal 2017, despite higher group profit and revenues. Further, the company lifted its final dividend, and said it is well-positioned to achieve a full year operating result in line with market expectations..
comments powered by Disqus
Follow RTT