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In Brief: Dermik Labs warning letter

This article was originally published in The Rose Sheet

Executive Summary

Dermik Labs warning letter: Firm plans to bring its Zetar shampoo into compliance with the OTC Drug Products' Final Monograph for the Control of Dandruff, Seborrheic Dermatitis and Psoriasis after receiving a warning letter from FDA. In the Dec. 30 letter, FDA denies the Rhone-Poulenc Rorer Pharmaceuticals division's request for a Certificate to Foreign Governments for Zetar, stating that Zetar is an unapproved new drug and is misbranded because of its lack of required directions for use and warning statements and its claims. Zetar was slated for sale in China...
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