Wyeth Cordarone I.V. (correction)
Executive Summary
Wyeth will ask FDA to amend Cordarone I.V. (amidarone) labeling to include safety data from a 61-patient trial used to request pediatric exclusivity for the antiarrhythmic. Labeling currently states that the safety and efficacy in the pediatric patients has not been established and references reports of fatal "gasping" syndrome in neonates associated with the preservative benzyl alcohol. FDA denied Wyeth six months of pediatric exclusivity citing "insufficient documentation"; the company does not believe it has recourse to appeal. "The Pink Sheet" (1Oct. 21, In Brief) incorrectly stated that Wyeth would ask FDA to reconsider its decision...