Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed - DTP vaccine
Status: withdrawn from the market
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; World mark.; Former
Cross ref: See the entries for Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#427); Tetanus Toxoid Products (#543); and Diphtheria Toxoid Products (#418). See the entries for component Diphtheria & Tetanus Toxoids Adsorbed (DT vaccine) (#421) from Wyeth.
Description: Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed was a combination vaccine formulated by mixture of three vaccines – Tetanus Toxoid Adsorbed, Diphtheria Toxoid Adsorbed, and Pertussis Vaccine Adsorbed from Wyeth (or affiliated Lederle Labs.).
Nomenclature: DTP Vaccine/Wyeth [BIO]; Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed [FDA since 1970]; Diphtheria & Tetanus Toxoids Alum Precipitated and Pertussis Vaccine Combined [FDA former]
Companies.: This DTP vaccine was manufactured and marketed in the U.S. by Wyeth, CBER/FDA est. no. 0003, at Marietta, PA, facilities (now closed).
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = 19610518; original approval, PLA; according to 1979 Office of Technology Assessment (OTA) list of vaccine approvals
Date = 19700827; license revoked and granted (reissued) for the product under the current FDA proper name
Date = 19700911; original approval date as reported in the official CBER/FDA database [wrong]
Status: In Jan. 2001, Wyeth announced it was discontinuing manufacture of all vaccines containing a tetanus toxoid component. FDA approval was voluntarily withdrawn.
Companies involvement:
Full monograph
450 DTP Vaccine/Wyeth
Nomenclature:
DTP Vaccine/Wyeth [BIO]
Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed [FDA since 1970]
Diphtheria & Tetanus Toxoids Alum Precipitated and Pertussis Vaccine Combined [FDA former name revoked in 1970]
DTP vaccine [SY]
FDA Class: BiologicPLA
Year of approval (FDA) = 1961
Date of 1st FDA approval = 19610518
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
Diphtheria Toxoid
formaldehyde
Pertussis Vaccine Adsorbed
Tetanus Toxoid
thimerosal (mercury derivative)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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