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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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