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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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ChloraPrep One-Step approval

Topical antiseptic consisting of chlorhexidine gluconate 2% and isopropyl alcohol 70% for preparation of skin prior to injection approved by FDA Oct. 7. NDA 21-555 was submitted on behalf of Medi-Flex Hospital Products by its agent, Beckloff Associates. In July 2000, agency approved the formulation as an OTC pre-operative skin prep (1"The Tan Sheet" July 24, 2000, In Brief). In April, FDA gave the nod to supplemental NDA 20-832/SCS-002 to change the ampoule size and volume and incorporate labeling changes on the pre-op skin preparation...

ChloraPrep One-Step approval

Topical antiseptic consisting of chlorhexidine gluconate 2% and isopropyl alcohol 70% for preparation of skin prior to injection approved by FDA Oct. 7. NDA 21-555 was submitted on behalf of Medi-Flex Hospital Products by its agent, Beckloff Associates. In July 2000, agency approved the formulation as an OTC pre-operative skin prep (1"The Tan Sheet" July 24, 2000, In Brief). In April, FDA gave the nod to supplemental NDA 20-832/SCS-002 to change the ampoule size and volume and incorporate labeling changes on the pre-op skin preparation...

ChloraPrep One-Step approval

Topical antiseptic consisting of chlorhexidine gluconate 2% and isopropyl alcohol 70% for preparation of skin prior to injection approved by FDA Oct. 7. NDA 21-555 was submitted on behalf of Medi-Flex Hospital Products by its agent, Beckloff Associates. In July 2000, agency approved the formulation as an OTC pre-operative skin prep (1"The Tan Sheet" July 24, 2000, In Brief). In April, FDA gave the nod to supplemental NDA 20-832/SCS-002 to change the ampoule size and volume and incorporate labeling changes on the pre-op skin preparation...

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