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
Consumers in Nigeria are calling for a boycott of Coca-Cola products sold in the African nation after a high court judge ruled that the products could be "poisonous". Justice Adedayo Oyebanji of the Lagos High Court ruled that high levels of benzoic acid and sunset additives in Coca-Cola's soft drinks could pose a health risk to consumers when mixed with ascorbic acid, commonly known as Vitamin C. Charles Murphy, a partner at New York hedge fund Paulson & Co., fell to his death after jumping out of a hotel window in Manhattan on Monday. Murphy was found dead on the fourth-floor terrace of the Sofitel New York Hotel after he jumped from a window on the 24th floor. Internet media company BuzzFeed is preparing to go public in 2018, media site Axios reported Wednesday, citing industry sources. New York-based BuzzFeed was founded in 2006 by Jonah Peretti and John Johnson III as a viral lab, focusing exclusively on tracking viral content.
comments powered by Disqus
Follow RTT