Off the newswire:

 

Sleep Disorders
Cephalon Receives FDA Approval of Nuvigil for the Treatment of Excessive Sleepiness
Cephalon announced that it has received approval from the FDA to market Nuvigil as a non-amphetamine, wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy and shift-work sleep disorder.

Nuvigil (armodafinil) is the single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil (modafinil) tablets, the company said.

The agency has approved final labeling for Nuvigil, including a bolded warning, which is consistent with the draft labeling received by the company in March.

As an aside, did you know that Modifinil is a performance enhancing agent on the banned list (IOC) but its isomer is not….yet….

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Sincerely,

Douglas Kalman PhD(c), RD
office 305-666-2368