The agency said the product is approvable to treat excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and "shift work" sleep disorder.
The FDA is also proposing a bolded warning on Nuvigil's labeling, advising of a potential risk of skin rash and hypersensitivity in patients taking Nuvigil(armodafinil), and on the labeling of a related Cephalon drug for narcolepsy-associated sleepiness, Provigil (modafinil).
The agency must approve the final labeling before Nuvigil can be marketed, the company said.
In addition, the FDA has asked Cephalon for a standard safety update from Nuvigil's clinical trials, as well as introductory promotional materials the company plans to include with the product.
Cephalon said it would submit the information within 30 days, with an agency response expected within 60 days thereafter.
The company said it would also test Nuvigil to treat other disorders including bipolar depression, cognition associated with schizophrenia, and excessive sleepiness and fatigue in diseases like Parkinson's and cancer.
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