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"