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Cephalon Announces FDA Approval of Risk Evaluation and Mitigation Strategies for NUVIGIL and PROVIGIL
Date:10/22/2010

icated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.  In patients with OSA, NUVIGIL is used along with other medical treatments for this condition.  The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).  NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia.  Full prescribing information for NUVIGIL is available at www.nuvigil.com.

About PROVIGIL PROVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy.  In patients with OSA, PROVIGIL is used along with other medical treatments for this condition.  The PROVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults and children taking modafinil.  PROVIGIL is not approved for use in pediatric patients for any indication.

The most common adverse events in controlled clinical trials (greater than five percent) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness and dyspepsia.  Full prescribing information for PROVIGIL is availabl
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SOURCE Cephalon, Inc.
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