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Salix, Progenics Announce FDA Extension Of RELISTOR SNDA Goal Date To July 27

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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.

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by RTT Staff Writer

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Consumers spent less in July than in the previous month, a surprise retreat that complicates the prevailing belief that the U.S. economic situation is improving. Along with the unexpected drop in spending, government figures released on Friday showed that incomes rose at a slower pace in July than in the previous month. Meanwhile, data on prices indicated that inflation pressures remain tame. India's economy grew faster-than-expected in the three months to June and at the strongest pace in two years, preliminary figures from the Central Statistics Office revealed Friday. Gross domestic product grew 5.7 percent in the April to June quarter, which exceeded economists' forecast for 5.5 percent expansion. The economy grew 4.6 percent in the previous three months. Eurozone inflation slowed as expected in August on falling energy prices giving room for the central bank to support demand and economic recovery without stoking inflation and help the region to create more jobs. The unemployment rate remained unchanged at an elevated level in July. Nonetheless, it was at the lowest since September 2012.
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