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.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement