Women's Health Weekly
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Business Update
FDA accepts ACEON supplemental new drug application for filing
March 17th, 2005
Solvay Pharmaceuticals, Inc., and CV Therapeutics, Inc., (CVTX) announced that the U.S. Food and Drug Administration (FDA) has accepted Solvay Pharmaceuticals' supplemental new drug application (sNDA) for ACEON (perindopril erbumine) Tablets for filing. The FDA has granted a 6-month priority review for the sNDA, setting the Prescription Drug User Fee Act date for June 10, 2005. Solvay Pharmaceuticals holds the new drug application for ACEON. CV Therapeutics and Solvay Pharmaceuticals recently entered into a copromotion agreement for ACEON, an angiotensin converting enzyme inhibitor with tissue activity approved in the United States for the treatment...
Source: Women's Health Weekly (2005-03-17)
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