ARTICLE | Clinical News

Cygnus Therapeutic Systems regulatory update

May 30, 1995 7:00 AM UTC

The FDA notified CYGN partner Warner-Lambert that an additional bioequivalency study is required for Fempatch, CYGN's seven-day estrogen patch. The agency is concerned about quality control specifications for one of the raw materials used in the patch. CYGN had conducted in vitro studies that demonstrated equivalency between earlier lots of Fempatch, but the FDA said the utility of the tests for predicting in vivo performance was not established. ...