Cephalon Provigil follow-on clears FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Approved labeling for Cephalon's follow-on compound armodafinil includes a bolded warning that a "serious rash requiring hospitalization and discontinuation of treatment" has been reported in patients using the product. Nuvigil was approved June 15 for excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy and shift work sleep disorder. 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). Rashes were seen in children taking the firm's Sparlon, which also has modafinil as its active ingredient, in studies for a potential attention deficit/hyperactivity disorder indication. Nuvigil had received an "approvable" letter in April 2006, with FDA requesting data on the rashes related to Sparlon (1Pharmaceutical Approvals Monthly May 2006, p. 19)...
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