Twenty-five thousand patient OCTAVE trial will generate data by the end of the second quarter of 2001 that could support a resubmission of the Vanlev NDA, Bristol says. Bristol hopes to show equivalence between Vanlev (omapatrilat) and Merck's ACE inhibitor Vasotec (enalapril) in incidence of angioedema. The company withdrew the NDA for Vanlev in April in response to FDA's concerns about the side effect (1"The Pink Sheet" April 24, p. 8)
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