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ChloraPrep One-Step NDA

This article was originally published in The Tan Sheet

Executive Summary

FDA approves NDA for chlorhexidine gluconate 2% and isopropyl alcohol 70% preoperative skin preparation July 14. The OTC topical antiseptic is indicated for professional use, the agency notes in its letter to Overland Park, Kan.-based Medi-Flex Hospital Products, finding "adequate information has been presented to demonstrate that the drug product is safe and effective for use"

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