Cephalon Adds Warning On Life-Threatening Skin Reaction To Provigil
This article was originally published in The Pink Sheet Daily
FDA requests updated labeling recommending the wakefulness drug be discontinued if a rash or hypersensitivity reaction occurs.
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Company tells “The Pink Sheet” DAILY it is set to begin studies in other therapeutic areas to boost labeling before commercial launch.
Cephalon plans to submit information to FDA within “the next few weeks.”
The company is seeking FDA accelerated approval of the closely watched gene therapy based on a surrogate marker and has proposed its fully enrolled Phase III trial to serve as a confirmatory study.