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Food and Drug Administration

Nov
3
2009
This entry was posted by admin on Tuesday, November 3, 2009 at 9:12 am (UTC), and is categorically filed in Shift Work, Top News.
Cephalon announced that Mayo Clinic Proceedings published data from a Phase III trial of Nuvigil (armodafinil) Tablets [C-IV] demonstrating it significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder.
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Respironics has issued a voluntary recall on two models of its SmartMonitor 2 Infant Apnea monitor after being notified by the U.S. Food and Drug Administration of potential problems.
The company issued a voluntary Class 1 recall, which are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
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Orexo has announced the U.S. Food and Drug Administration (FDA) has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Meda, Orexo’s partner, acquired exclusive worldwide commercial licensing for Edluar in 2008 with expectations to launch the product in the U.S. market during the second half of 2009. Orexo will receive royalties based on Meda’s sales of Edluar.
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Interesting Apnea Statistics
~~ Apnea in United States ~~
As of May 2, 2009 at 9:47 p.m. (-0500) (ET), the U.S. population
was 306,340,710. Sleep researchers estimate approximately seven percent
of the population suffers from obstructive sleep apnea. Using that
estimate, there are potentially 21,443,850 apneics in the U.S.
~~ Apnea around the world ~~
As of May 2, 2009 at 9:47 p.m. (-0500) (ET), the world population
was 6,777,286,604. Sleep researchers estimate approximately seven percent
of the population suffers from obstructive sleep apnea. Using that
estimate, there are potentially 474,410,062 apneics in the world.