Women's Health Weekly
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Cardiovascular Disease
U.S. FDA grants priority review for ACEON sNDA
February 10th, 2005
Solvay Pharmaceuticals, Inc., and CV Therapeutics, Inc., (CVTX) announced that the U.S. Food and Drug Administration (U.S. FDA) has formally notified Solvay Pharmaceuticals that their supplemental new drug application (sNDA) for ACEON (perindopril erbumine) Tablets seeking an expansion to the label will receive a priority review, pending FDA filing of the application. The proposed label expansion is based on the EUROPA (European trial on reduction of cardiac events with Perindopril in patients with stable coronary artery disease) study which assessed the ability of perindopril to reduce cardiovascular mortality, nonfatal myocardial infarction, and cardiac arrest in a...
Source: Women's Health Weekly (2005-02-10)
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