FDA APPROVAL STAUS OF PYRIDOSTIGMINE BROMIDE AND DIAZEPAM

File: 970101_sep96_decls41_0001.txt
Page: 0001
Total Pages: 1

Subject: FDA APPROVAL STAUS OF PYRIDOSTIGMINE BROMIDE AND DIAZEPAM       

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: FDA APPROVAL STATUS OF PYRIDOSTIGMINE BROMIDE AND THE DIAZEPAM AUTOINJECTOR                     

Document Number:       1001

Folder Seq  #:         50



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                                 INFORMATION PAPER


                                                                   SGPS-PSP
                                                            7 January 1991

        SUBJECT: FDA Approval Status of Pyridosticjmine Bromide and
        the Diazepam Autoinjector

        1. PURPOSE: To provide the latest information on the approval
        status of pyridosticjmine and diazepam in support of operation
        Desert Shield.


        2. FACTS:

            a. An Investigational New Drug (IND) application, sponsored
        by the U.S. Army Office of the Surgeon General, was submitted to
        the Food and Drug Administration (FDA) in January 1984, for use
        of pyridostigmine bromide in the pretreatment of nerve agent
        poisoning.

            b. Use of pyridosticjmine under provisions of the IND would
        normally require the informed consent of soldiers using the
        product. Since informed consent in a battlefield scenario may
        not be feasible and is contrary to the best interests of the
        soldier, the Assistant Secretary of Defense for Health Affairs
        petitioned the FDA on 28 December 1990 for relief from the
        informed consent requirements for pyridostigmine. The FDA's
        decision on the informed consent waiver is anticipated within the
        next week; a favorable determination is anticipated.

            C. A New Drug Application (NDA) was also submitted to the
        FDA on 16 October 1990 for use of diazepam autoinjectors in the
        treatment of severely intoxicated nerve agent casualties. The
        NDA for diazepam autoinjectors was approved by the FDA on 5
        December 1990. Informed consent will not be required for use of
        the diazepam autoinjector in support of Operation Desert Shield,
        provided that the FDA accepts the current labelling instructions
ipped to the theatre.


                                                     MAJ McIntosh/756-0133






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Document 1 f:/Week-36/BX003201/FDA APPROVAL STATUS OF PYRIDOSTIGMINE BROMIDE AND THE DIAZEPAM AUTOINJECTOR/fda approval staus of pyridostigmine bromide and:12249609313342
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = FDA APPROVAL STATUS OF PYRIDOSTIGMINE BROMIDE AND THE DIAZEPAM AUTOINJECTOR
Folder Seq # = 50
Subject = FDA APPROVAL STAUS OF PYRIDOSTIGMINE BROMIDE AND
Document Seq # = 1001
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 24-DEC-1996