Adsorbed/Wyeth
Tetanus and Diphtheria Toxoids Adsorbed for Pedia-tric Use Ultrafined; DT vaccine
Status: withdrawn from the market
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; Former
Cross ref: See the entries for a component vaccine, Tetanus Toxoid Adsorbed (#554). See the Tetanus Toxoid Vaccines (#543) and Diphtheria Toxoid Products (#418) entries. See also the DTP and DTaP vaccines from Wyeth incorporating this vaccine.
Description: Diphtheria & Tetanus Toxoids Adsorbed is a combination vaccine formulated by mixture of two vaccines, Tetanus Toxoid Adsorbed and Diphtheria Toxoid Adsorbed, from Wyeth (formerly Lederle Labs.). This combination was apparently used by Wyeth/Lederle for further manufacture of its DTP and DTaP vaccines.
Nomenclature: Diphtheria & Tetanus Toxoids Adsorbed/Wyeth [BIO]; Diphtheria & Tetanus Toxoids Adsorbed [FDA]
Companies.: The vaccine was manufactured by Wyeth Pharmaceuticals, FDA CBER est. no. 0003.
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = unknown; original approval date no longer reported (lost) by FDA
Date = 19700911; first approval, according to the CBER/FDA database and other FDA sources (wrong). The proper names for this and other adsorbed toxoid-containing vaccines from Wyeth were changed on this date, with the product license revoked and granted (reissued) using the current proper name.
Indications: product insert/labeling not available
Status: Approval was voluntarily revoked by Wyeth in late 2003 (or early 2004). This vaccine was apparently used for further manufacture of DTP and DTaP vaccines by Wyeth. In Jan. 2001, Wyeth announced it was discontinuing manufacture of tetanus toxoid and vaccines containing a tetanus toxoid component, including this vaccine.
Companies involvement:
Full monograph
421 Diphtheria & Tetanus Toxoids
Nomenclature:
Diphtheria & Tetanus Toxoids Adsorbed/Wyeth [BIO]
Diphtheria & Tetanus Toxoids Adsorbed [FDA]
FDA Class: Biologic PLA
Year of approval (FDA) = 1970
Date of 1st FDA approval = 19700911
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Clostridium tetani
Corynebacterium diphtheriae
Diphtheria Toxoid
formaldehyde
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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