3 source-based articles maintained by the HealthRX.com Editorial Team.
Showing 3 of 3 clinical reviews.
A complete timeline of Provigil (modafinil) FDA approval, label revisions, post-market safety actions, and current regulatory status for narcolepsy, OSA, and shift-work disorder.
A clinical guide to the FDA regulatory status of modafinil (Provigil), its compounding eligibility under federal law, and what prescribers should understand about 503A and 503B pathways.
The FDA modafinil label warns of serious rash (SJS, TEN, DRESS), psychiatric events like mania and suicidal ideation, and cardiac caution in heart disease.