MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0005.txt
Page: 0005
Total Pages: 11

Subject: MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT     

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: MEDICAL PRODUCTS UNDER FDA REGULATIONS                                                          

Document Number:     930001

Folder Seq  #:     930000









         5. Pyridostigmine Bromide 30 mg tablets.

             a. ANDA # 89-572 (under FDA review), sponsored by Kalipharma
         Inc. The ANDA was determined to be acceptable on 15 June 1988.
         IND # 23,509 is sponsored by the US Army Office of the Surgeon
         General.

             h. Manufacturer - Duphar BV, The Netherlands.

             c. Indication: The indication cited in the ANDA is for the
         treatment of myesthenia gravis. The indication intended for use,
         if necessary, in Operation Desert Shield is for the pretreatment
         of nerve agent poisoning.

             d. operation Desert Shield Status: Pyridostigmine 30 mg
         tablets are currently on site at Operation Desert Shield. Based
         on interactions with the FDA, and a classified letter from the
         Director, Office of New Drug Evaluation, NCDB, FDA, 25 October
         1983, pyridostigmine bromide 30 mg tablets (packets of 21
         tablets) were fielded in the mid-1980s by the Services for use by
         service members as a pretreatment for nerve agent poisoning. The
         use of pyridostigmine bromide as a pretreatment under threat of
         nerve agent attack is approved doctrine in the US military and in
         NATO countries. The Defense Personnel Support Center (DPSC) in
         Pennsylvania has recently contracted for        to produce
         additional tablets for delivery to Mechanicsburg, Pennsylvania,
         which is a DPSC depot.

             e. Consequences of not using pyridostigmine pretreatment in
         operation Desert Shield: Mortality rates associated with
         chemical warfare nerve agent attacks are expected to be greater
         without pyridostigmine pretreatment.

             f. Informed consent status: Informed consent will not be
         feasible.

             g. Production Availability: 21 September 1990.

             h. Point of contact: Dr. Clawson, 301-663-2051

Document 11 f:/Week-36/BX003201/MEDICAL PRODUCTS UNDER FDA REGULATIONS/medical prod under fda reg required consider for:01029715471415
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = MEDICAL PRODUCTS UNDER FDA REGULATIONS
Folder Seq # = 930000
Subject = MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR
Document Seq # = 930001
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 = 02-JAN-1997