MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0008.txt
Page: 0008
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









         2. J-5 Monoclonal Antibody (Cehtoxin)

             a. IND # BB-IND-2283, sponsored by Centocor. A separate new
         IND will be submitted under sponsorship by the Office of the
         surgeon General, US Army.

             b. Manufactured by Centocor.

             C. Indication: Centoxin is indicated for the treatment of
         septic patients with a presumptive diagnosis of gram negative
         bacteremia, including those with septic shock. The indication
         cited in the IND is the indication intended for use in Operation
         Desert Shield.

             d. operation Desert Shield status: required immediately.
             e. consequences of not using J-5 Monoclonal Antibody in
         operation Desert Shield: Increased mortality and morbidity in
         burned or wounded soldiers with septicemia or septic shock. This
         is not a treatment for biologic warfare threats.

             f.  Informed consent status: undetermined, pending.

             g. Production Availability: 10 September 1990.

             h. Point of contact: Dr. Roy, 301-663-7661

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