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...