A Case Study on the FDA Approval of Medical Treatments against Nerve Agent Poisoning

Lee, Keunwoo; An, Seoyeon; Hur, Byungil

doi:2016.19.1.119

J. KIMS Technol > Volume 19(1); 2016 > Article

Journal of the Korea Institute of Military Science and Technology 2016;19(1):119-126.
DOI: https://doi.org/10.9766/KIMST.2016.19.1.119

A Case Study on the FDA Approval of Medical Treatments against Nerve Agent Poisoning

Keunwoo Lee, Seoyeon An, Byungil Hur

Samyang Chemical Research Institute of Technology Development

신경작용제 해독제 의약품 품목허가 사례 연구

이근우, 안서연, 허병일

삼양화학공업 기술연구소

Abstract

The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.

Key Words: Antidote, Nerve Agent, Autoinjector