Althera Life Sciences, LLC: rosuvastatin

Please refer to your new drug application (NDA) dated and received July 29, 2019, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for rosuvastatin and ezetimibe tablet.

Satisfactory resolution of these deficiencies is required before this application may be approved.

As part of your PREA requirement, you would be responsible for addressing this evidence gap in FDA's previous findings of pediatric safety and efficacy for ezetimibe with either evidence from published literature or from a completed trial in pediatric patients in the resubmission.

Published RCTs do not need to be limited to trials with treatment arms comparing ezetimibe monotherapy versus placebo.