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

Editors Pick
Chipotle Mexican Grill Inc. (CMG) on Monday reported a surge in profit for the first quarter, as revenues climbed 20 percent on new restaurant openings and strong same-restaurant sales. Earnings for the quarter trounced Wall Street expectations, but revenues fell short of estimates, hurt largely... Yahoo reported a plunge in profit, hurt by lower prices for display ads as well as one-time charges. Its results fell short of Street estimates, denoting the challenges CEO Marissa Mayer faces in implementing her turnaround plans at the Internet company. Amgen Inc. (AMGN) on Tuesday reported a surge in profit for the first quarter, as revenues grew 11 percent on better pricing and strong demand with research costs falling. Both earnings and revenues for the quarter trumped analysts' estimates. Moving ahead, the drug maker raised its outlook for the full...
comments powered by Disqus
RELATED NEWS
Trade SLXP now with 
Follow RTT