|
Vaccine and Company
|
Review Time (months)
|
FDA Approval
|
Characteristics
|
|
Haemophilus influenzae type b conjugate (diphtheria toxoid conjugate)
|
55.4
|
12/1987
|
New vaccine (18–60 months)
|
|
Connaught Laboratories, Inc.
|
|
|
|
|
Hepatitis B vaccine, recombinant
|
18.0
|
07/1986
|
New vaccine
|
|
Merck & Co., Inc.
|
|
|
|
|
Hepatitis B vaccine, recombinant
|
20.8
|
08/1989
|
Independent introduction
|
|
SmithKline Beecham
|
|
|
|
|
Influenza virus vaccine
|
17.3
|
08/1988
|
New introduction of old vaccine
|
|
Evans Medical, Ltd.
|
|
|
|
|
Japanese encephalitis virus, inactivated
|
30.8
|
12/1992
|
New vaccine
|
|
Research Foundation of Osaka University
Connaught Laboratories, Inc.
|
|
|
|
|
Poliovirus vaccine, inactivated
|
16.1
|
11/1987
|
Enhanced poliovirus vaccine
|
|
Connaught Laboratories, Inc.
|
|
|
|
|
Poliovirus vaccine, inactivated
|
93.3
|
12/1990
|
Independent introduction
|
|
Pasteur Mérieux Sérums et Vaccins
|
|
|
|
|
Rabies vaccine, adsorbed
|
93.3
|
03/1988
|
Independent introduction
|
|
Michigan Department of Public Health
|
|
|
|
|
Rabies vaccine
|
42.4
|
12/1991
|
Independent introduction
|
|
Connaught Laboratories, Inc.
|
|
|
|
|
Typhoid vaccine, live oral (Ty21a)
|
92.5
|
12/1989
|
New vaccine
|
|
Swiss Serum & Vaccine Institute, Berne
|
|
|
|
|
SOURCES: New Drug Approvals in 1991, Pharmaceutical Manufacturers Association, January 1992; New Drug Approvals in 1990, Pharmaceutical Manufacturers Association, January 1991; New Drug Approvals in 1989, Pharmaceutical Manufacturers Association, January 1990; Biotechnology Medicines, Pharmaceutical Manufacturers Association, 1990, Douglas Reynolds, Connaught Laboratories. Swiftwater, Pennsylvania, October 1992; Carolyn Hardegree, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.
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