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news.Cephalon's Risk Evaluation and Mitigation Strategies (REMS) for its medications Nuvigil (armodafinil) tablets [C-IV] and Provigil (modafinil) tablets [C-IV] have received approval from the US Food and Drug Administration (FDA).
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Nuvigil and Provigil are indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD) or narcolepsy.
The goal of each REMS is to inform healthcare providers, patients and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions.
The current product labeling for both medications contains a bolded warning that includes these risks.
Neither medication is approved for use in the pediatric population for any indication.
In accordance with the approved REMS, Cephalon is currently updating Nuvigil and Provigil labeling to include the Medication Guide.