Schering AG/Berlex Angeliq second try
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering AG/Berlex expect a six-month review for Angeliq (drospirenone/estradiol) with the late March filing of a "complete response" for the hormone replacement therapy. Angeliq received a "not approvable" letter Oct. 17, 2002 in the wake of the Women's Health Initiative study results (1Pharmaceutical Approvals Monthly Nov. 1, 2002, In Brief). The firm is touting a potential anti-hypertensive effect with Angeliq...