Posted by Michael Wonder on 06 May 2019
Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review
5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target date goal for the bempedoic acid / ezetimibe combination tablet.
Esperion announced today that the U.S. FDA has accepted both new drug applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review.
Bempedoic acid and the bempedoic acid / ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies.
