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Penederm's retinoic acid acne products are "nonapprovable at this time" -- FDA.

This article was originally published in The Rose Sheet

Executive Summary

PENEDERM's RETINOIC ACID ACNE PRODUCTS ARE "NONAPPROVABLE" at this time, FDA told the firm. The Foster City, CA-based dermatologic products company announced on April 25 that it had received a nonapprovable letter, 12 months after filing new drug applications for its prescription retinoic acid gel and cream for the treatment of acne. In handing out the nonapprovable decision, FDA cited issues relating to manufacturing and controls processes and the need for additional clinical data on the products, the company stated.



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