Warner Lambert FemPatch approved Dec. 3; estradiol patch manufacturers to add adhesion data to labeling.
Executive Summary
WARNER-LAMBERT FEMPATCH ESTRADIOL PATCH ADHESION DATA will be submitted as supplemental labeling revisions to the NDA, which was approved by FDA on Dec. 3. Warner-Lambert will also pursue labeling revisions to include efficacy results from clinical studies on the estradiol transdermal system.