Wyeth Cordarone I.V.
Executive Summary
Wyeth will ask FDA to reconsider its decision to deny pediatric exclusivity for the antiarrhythmic Cordarone I.V. FDA concluded that the company had provided "insufficient documentation to meet the provisions of the agency's request." Wyeth conducted a 61-patient study in 27 centers in the U.S. and five other countries. Half the patients were from the U.S. Cordarone I.V (amiodarone) was approved in August 1995 under orphan drug status; six months of pediatric exclusivity would have extended protection to Feb. 3, 2003...
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Wyeth Cordarone I.V. (correction)
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...
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