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News Breaks
January 10, 2013
13:05 EDTSNY, TSPTFDA doesn't require labeling changes for Intermezzo in review of sleep aids
The FDA announced earlier that it is requiring Sanofi (SNY), the manufacturer of Ambien, and some makers of other insomnia drugs that contain zolpidem, to lower the recommended dose. The FDA said the recommended bedtime dose should be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. The FDA said recommended doses of Transcept Pharmaceuticals' (TSPT) Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men, the FDA noted. In afternoon trading, shares of Transcept rose 16c, or 3.04%, to $5.43. Reference Link
News For TSPT;SNY From The Last 14 Days
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November 24, 2015
05:23 EDTSNYSanofi, Regeneron announce Praluent ODYSSEY OUTCOMES trial enrollment complete
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November 20, 2015
06:09 EDTSNYSanofi, AstraZeneca to exchange more than 210,000 compounds
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November 18, 2015
08:11 EDTSNYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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