Barr Bijuva Estrogen Cream "Not Approvable"; Only Meets 2 Of 3 Endpoints
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Barr's NDA for Bijuva (synthetic conjugated estrogens, A) cream is "not approvable" at FDA due to the menopause therapy's failure to meet all three clinical endpoints, the company said April 26