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
Chipmaker Qualcomm is reportedly in talks with NXP Semiconductor NV (NXPI) for a possible acquisition, reports said. According to Bloomberg, negotiations are on with a probable price of $110 t $120 per NXP share. The deal would value NXP at around $34.7 billion. Regulators have confirmed the eleventh U.S. fatality linked to Takata Corp.'s defective air bag inflators. The National Highway Traffic Safety Administration or NHTSA said Thursday that a crash fatality in Riverside County, California, was tied to the rupture of a recalled Takata air bag inflator. Reynolds American Inc. (RAI) on Friday confirmed that British American Tobacco plc (BATS.L, BTI) has offered to buy the remaining 57.8 percent stake that it does not own in the US tobacco company for $47 billion. Reynolds said its board of directors will evaluate the offer, and respond accordingly to BAT, which currently owns 42.2 percent stake in Reynolds. The proposal represents an enterprise va
comments powered by Disqus
Follow RTT