|
Vaccine and Company
|
Review Time (months)
|
FDA Approval
|
Characteristics
|
|
BCG live
|
18.1
|
05/1990
|
New approval of an old vaccine for limited indication (treatment of carcinoma-in-situ of the urinary bladder
|
|
Connaught Laboratories, Inc.
|
|
|
|
|
BCG vaccine
|
29.5
|
08/1990
|
New approval of old vaccine (also indicated for the treatment of carcinoma-in-situ of the urinary bladder
|
|
Organon Teknika Corporation
|
|
|
|
|
Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP)
|
51.5
|
12/1991
|
New acellular pertussis component; shared manufacture with Takeda Chemical Industries, Ltd.
|
|
Lederle-Praxis Biologicals
|
|
|
|
|
Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP)
|
27.1
|
08/1992
|
New acellular component; shared manufacture with Biken (Research Foundation of Osaka University)
|
|
Connaught Laboratories, Inc.
|
|
|
|
|
Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed and Haemophilus influenzae type b conjugate
|
14.9
|
03/1993
|
New vaccine
|
|
Lederle-Praxis Biologicals
|
|
|
|
|
Haemophilus influenzae type b meningococcal outer membrane conjugate vaccine
|
24.9
|
12/1989
|
New vaccine (18–60 months)
|
|
Merck & Co., Inc.
|
|
|
|
|
Haemophilus influenzae type b meningococcal outer membrane conjugate vaccine
|
4.1
|
12/1990
|
Infant indication
|
|
Merck & Co., Inc.
|
|
|
|
|
Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate)
|
27.8
|
03/1993
|
New vaccine
|
|
Pasteur Mérieux Sérums et Vaccins
|
|
|
|
|
Haemophilus influenzae type b and diphtheria CRM 197 protein conjugate vaccine
|
22.5
|
12/1988
|
New vaccine (18–60 months)
|
|
Praxis Biologics, Inc.
|
|
|
|
|
Haemophilus influenzae type b conjugate vaccine
|
6.9
|
10/1990
|
Infant indication
|
|
Praxis Biologics, Inc.
|
|
|
|
