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Pfizer Inspra submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer submits sNDA in April for use of its selective aldosterone blocker Inspra (eplerenone) for congestive heart failure. The sNDA is based on the EPHESUS trial, which showed a mortality reduction for post-MI patients receiving eplerenone (1Pharmaceutical Approvals Monthly March 1, p. 23). The firm said April 22 that Inspra would not be launched until the CHF indication is cleared; the antihypertensive was first approved Sept. 27, 2002, for hypertensio

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