Cephalon Adds Warning On Life-Threatening Skin Reaction To Provigil
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA requests updated labeling recommending the wakefulness drug be discontinued if a rash or hypersensitivity reaction occurs.
You may also be interested in...
FDA Approves Cephalon’s Nuvigil With Bolded Warning For Rash
Company tells “The Pink Sheet” DAILY it is set to begin studies in other therapeutic areas to boost labeling before commercial launch.
Nuvigil May Be Further Delayed As FDA Reviews Side Effect Profile
Cephalon plans to submit information to FDA within “the next few weeks.”
Sarepta Files DMD Gene Therapy, Seeking An Accelerated Path To Market
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.