Provigil Label: Panel’s “Not Recommended” Language Could Be Template
Executive Summary
Language that specifically warns against using Cephalon's Provigil in pediatric patients should be added to the drug's labeling, FDA's Pediatrics Advisory Committee recommended Nov. 27
You may also be interested in...
FDA Rejects Sparlon Due To Single SJS Case; An Ominous Sign For Pharma?
FDA's decision that Cephalon's attention deficit hyperactivity disorder treatment Sparlon is not approvable - based on an adverse event in a single patient - could be indicative of a more challenging regulatory environment for manufacturers
Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
Track-And-Trace: With Deadline a Year Away, Some Lessons from Early Adopters
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.