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In Brief: Penederm

This article was originally published in The Tan Sheet

Executive Summary

Penederm: Submits amendments to its NDAs for retinoic acid cream and gel products for treatment of acne to FDA, the company announces Jan. 3. FDA issued a "nonapprovable" letter to the company in April, one year after the NDA filings, citing manufacturing and control issues and the need for clarified clinical data. Penederm initiated a 90-day clinical trial on the side-effect profile of its products at the end of September, although FDA said it did not need the additional data. The dermatological company's retinoic acid products, which use a patented drug delivery technology, are marketed in Canada by PharmaScience under the trade name Vitinoin...
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