Cellegy Fortigel “not approvable”
Executive Summary
Cellegy plans to meet with FDA in "next month or so" to discuss agency concerns about elevated serum testosterone levels associated with Fortigel. FDA issued "not approvable" letter for testosterone gel citing "insufficient information" in NDA to demonstrate that "high supraphysiologic daily Cmax serum testosterone levels achieved in a significant portion of participants" in clinical trials "are safe under conditions of chronic administration," Cellegy says...