Anonymous
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Anonymous
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This time, it's Cadence Pharmaceuticals(CADX Quote), which said Friday that FDA is pushing back review of its intravenous acetaminophen by three months. The new approval decision date is now Feb. 12, 2010.
Last week, the FDA also delayed by three months a review of a restless leg syndrome drug by GlaxoSmithKline(GSK Quote) and Xenoport(XNPT Quote). The FDA has had difficulty meeting drug approval review deadline this year, in part because of staffing shortages but also because of the agency's renewed focus on drug safety.
Cadence is developing its intravenous acetaminophen for use in hospitalized patients. The drug's U.S. and Canadian marketing rights was licensed from Bristol-Myers Squibb(BMY Quote), which already sells the drug in Europe.
HA, guess the grass isnt greener after all!!
Not the only drug you dope! See below!
Last week, the FDA also delayed by three months a review of a restless leg syndrome drug by GlaxoSmithKline(GSK Quote) and Xenoport(XNPT Quote). The FDA has had difficulty meeting drug approval review deadline this year, in part because of staffing shortages but also because of the agency's renewed focus on drug safety.