Berlex HRT agents "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering AG U.S. subsidiary Berlex receives "not approvable" letter for hormone replacement therapy Angeliq (drosperinone) Oct. 17 and is seeking "active dialogue" to learn more about FDA's concerns. Schering AG is pointing to concerns about HRT raised in Women's Health Initiative study. The firm's estradiol/ levonorgestrel patch (formerly Climara) was deemed "not approvable" Oct. 8. FDA cited technical aspects of one of the clinical studies in the NDA, Berlex indicated. The patch received an earlier "not approvable" letter June 27, 200