MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0002.txt
Page: 0002
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. Ribavirin Injection, IV, 1 gram vials in a 10 ml buffered
         solution.

             a. IND # 16,666, sponsored by the US Army Office of the
         Surgeon General. Viratech sponsors three INDS: #9076 for oral
         and injectable ribavirin, #17111 for aerosol, and #27296 (?).
         CDC sponsors IND #17186 for ribavirin(?). Lederle sponsors IND
         #10293.

             b. NDA 18-859 is approved for aerosolized ribavirin for the
         treatment of respiratory syncytial virus in infants.

             b. Manufacturer: Viratech

             C. IND listed indication: Hemorrhagic Fever with Renal
         Syndrome. The indication intended for use in Operation Desert
         Shield is for the treatment of Crimean Congo Hemorrhagic
         Fever,which is a hemorrhagic fever with renal syndrome.

             d. Operation Desert shield status: required immediately.

             e. Projected Availability for Operation Desert Shield: 7
         October 1990.

             f. Consequences of nontreatment: 30% mortality untreated.

             g. Informed consent status: undetermined

             f. Point of Contact: Dr. Liu, 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