FDA Accepts Aceon Supplemental New Drug Application for Filing

Solvay Pharmaceuticals and CV Therapeutics has announced that the FDA has accepted Solvay Pharmaceuticals' supplemental new drug application (sNDA) for Aceon tablets for filing.

The FDA has granted a six month priority review for the sNDA, setting the Prescription Drug User Fee Act date for June 10. Solvay holds the NDA for Aceon (perindopril erbumine).

CV Therapeutics and Solvay recently entered into a co-promotion agreement for Aceon, an angiotensin converting enzyme inhibitor with tissue activity approved in the U.S. for the treatment of patients with essential hypertension.