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In Brief: Penederm

This article was originally published in The Rose Sheet

Executive Summary

Penederm: Firm says in an Aug. 9 letter to shareholders that it believes it has addressed the chemistry, manufacturing and controls issues raised by FDA in a recent "nonapprovable" letter regarding the company's NDAs for retinoic acid products. Penederm announced receipt of the letter from FDA in April ("The Rose Sheet" May 1, p. 5). The company said it expects discussions with FDA on outstanding clinical issues will continue over the next several months. Penederm plans to initiate an additional 90-day acne trial in September to supplement its current clinical data package if needed, and to provide additional clinical support for claims related to the acne treatments...
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