Aceon aces supplemental review
Executive Summary
Solvay/CV Therapeutics' ACE inhibitor Aceon (perindopril) receives sNDA approval Aug. 23 for treatment of patients with stable coronary artery disease. Aceon was previously approved for treatment of essential hypertension. Solvay was granted priority review following its December sNDA submission, but FDA instituted a three-month extension in June to allow for additional audits of trial sites from the 12,000-patient European trial...