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Upsher Smith Amlactin 12% ammonium lactate cream is unapproved new drug -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

AMLACTIN 12% AMMONIUM LACTATE MARKETED APPROPRIATELY AS COSMETIC, Upsher Smith Labs maintains in response to a recent warn-ing letter from FDA declaring the topical lotion and cream to be unapproved new drugs. The Minneapolis-based company conveyed its position to the agency in an Aug. 24 letter. Following a review of Amlactin labeling and promotional materials, FDA informed Upsher Smith in an Aug. 5 letter it believes the products are intended for the "cure, mitigation, treatment or prevention of disease" or "to affect the structure or any function of the body." However, the firm does not plan to modify its product formulations and maintains its marketing claims are appropriate for a cosmetic moisturizer.
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