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
Anglo-Dutch oil giant Royal Dutch Shell plans to cut 2,200 more jobs, as the company continues to face lower oil prices, media reported Wednesday citing an emailed statement. The latest round of cuts would bring the total job cuts this year to at least 5,000 globally. In the U.K. and Ireland, the company plans to reduce staff working in exploration and production by 475. Tiffany & Co. (TIF) reported first-quarter net earnings of $87 million, or $0.69 per share compared to $105 million, or $0.81 per share, in the prior year. The company noted that its first-quarter results included a tax benefit of $0.05 per share related to the settlement of a tax examination. On average,... Shares of Marks & Spencer Group plc were losing around 8 percent in the early morning trading in London, after the retailer reported lower profit in its fiscal 2016, hurt mainly by weak results at clothing & Home segment and lower UK LFL sales. Looking ahead, the company warned about profit, and said it sees a similar sales trend in fiscal 2017.
comments powered by Disqus
Follow RTT