FDA EXTENDS PDUFA DATE FOR ACEON BY 90 DAYS
Solvay Pharmaceuticals and CV Therapeutics has announced that the FDA has informed Solvay Pharmaceuticals that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the ACEON (perindopril erbumine) tablets supplemental new drug application by 90 days, and the PDUFA date is now Sept. 10, 2005. The purpose of the extension is to allow time for additional clinical site audit activities at certain EUROPA study sites.
ACEON is an angiotensin-converting enzyme approved in the U.S. for the treatment of patients with essential hypertension. The supplemental new drug application, which was granted a six-month priority review by the FDA, seeks an expansion to the existing label based on the EUROPA (European trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study.