FDA Rejects Sparlon Due To Single SJS Case; An Ominous Sign For Pharma?
Executive Summary
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
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FDA not rash in approving Nuvigil
Cephalon's Nuvigil (armodafinil) approved June 15 for excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy and shift-work sleep disorder. Approved labeling includes a bolded warning that a "serious rash requiring hospitalization and discontinuation of treatment" has been reported in patients using the product. The bolded warning adds that Nuvigil is not approved for use by children for any indication. A similar warning will be added to labeling for Cephalon's first-generation product Provigil (modafinil). Nuvigil had received an "approvable" letter in April 2006, with FDA requesting data on rashes in patients taking another modafinil-containing drug, Sparlon (1"The Pink Sheet" Aug. 21, 2006, p. 7)...