In Brief: Penederm
This article was originally published in The Tan 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 April 25 that it had received the letter ("The Tan Sheet" May 8, p. 18). The company said it expects that discussions with FDA regarding 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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