The company also agreed that an offence against the Federal Food, Drug and Cosmetic Act and enter into a corporate integrity agreement with the HHS Office of Inspector General.
Earlier this year, the Food and Drug Administration a warning letter to Cephalon for off-label promotion of Provigil (modafinil). A promotional piece said Provigil treated various diseases, including those related to fatigue, even if the drug is not fatigue.
The formal notice said Provigil was also promoted to another state shortly after Cephalon received a non-approvable letter for the Indication.
Congress also examined Cephalon & 39; promotion activities. House Oversight Services and Government Reform Chairman Henry Waxman asked Cephalon for advertising and research information for their narcotic painkiller Actiq and Fentora.
If you or a loved one has taken Provigil and experienced serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal Necrolysis, please contact an attorney to Specter, Specter, Evans, & Manogue for a free case to be reviewed.
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