Inspra Efficacy In Blacks Insufficient For Superiority Claim, Priority Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A superiority claim for Pharmacia’s anti-hypertensive Inspra for increased efficacy in black patients would require replicated efficacy in large placebo-controlled trials, FDA said in review documents.
You may also be interested in...
Pfizer Inspra submission
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
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product