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Zimycan NDA

This article was originally published in The Tan Sheet

Executive Summary

Barrier Therapeutics expects a first-action letter from FDA relating to approval of its prescription Zimycan ointment for diaper dermatitis complicated by candidiasis during the first half of 2005, and is gearing up for potential launch in the second half, according to Chief Commercial Officer Al Altomari. Barrier acquired rights for the product in a 2002 licensing agreement with J&J, following a failed attempt to gain OTC clearance (1"The Tan Sheet" Aug. 16, 2004, p. 9). Barrier recently submitted results of a Phase III trial showing significant efficacy superiority versus vehicle in an amendment to its NDA...
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