Lederle
Diphtheria & Tetanus Toxoids Adsorbed Purogenated for Pediatric Use; DT vaccine
Status: withdrawn from the market
Organizations involved:
Wyeth – USA mark.; Parent; Former
Lederle Labs. – Manuf.; R&D; Tech.; Former
Cross ref: See the entries for Tetanus Toxoid Vaccines (#543), Diphtheria Toxoid Products (#418), and Wyeth’s Tetanus Toxoid Adsorbed (#554). See also the DTP and DTaP vaccines from Wyeth/Lederle formerly incorporating this vaccine. See the Diphtheria & Tetanus and Pertussis Vaccines (DTP/DTaP) Products entry (#429).
Description: Diphtheria & Tetanus Toxoids Adsorbed was a combination vaccine formulated by mixture of two vaccines, Tetanus Toxoid Adsorbed and Diphtheria Toxoid Adsorbed from Lederle/Wyeth.
Nomenclature: Diphtheria & Tetanus Toxoids/Lederle [BIO]; Tetanus and Diphtheria Toxoids Adsorbed [FDA]; Diphtheria & Tetanus Toxoids Adsorbed Purogenated for Pediatric Use [FDA full name on insert/labeling]; Diphtheria and Tetanus Toxoids Combined Aluminum Phosphate Adsorbed [FDA former]
Companies.: Diphtheria & Tetanus Toxoids Adsorbed was manufactured by the Lederle Labs., CBER/FDA lic. no. 0017, subsidiary of Wyeth, which formerly marketed the vaccine.
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = 19490726; first approval according to 1979 Office of Technology Assessment (OTA) vaccines approvals list
Date = 19540322; first approval according to Wyeth
Date = 19700729; first approval according to the CBER/FDA database; However, an FDA letter reports that on this date the product license was revoked and granted (reissued) using the current FDA proper name.
Indications: current product insert not available
Status: In early 2001, Wyeth-Ayerst announced it was discontinuing manufacture of all vaccines containing a tetanus toxoid component. The product license was voluntarily revoked by Wyeth.
Companies involvement:
Full monograph
426 Diphtheria & Tetanus Toxoids/
Nomenclature:
Diphtheria & Tetanus Toxoids/Lederle [BIO]
Diphtheria & Tetanus Toxoids Adsorbed [FDA]
Diphtheria & Tetanus Toxoids Adsorbed Purogenated for Pediatric Use [FDA on insert/labeling]
Diphtheria and Tetanus Toxoids Combined Aluminum Phosphate Adsorbed [FDA former name replaced by current name in July 1970]
DT Vaccine [SY]
NDC 0005-1858-31 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1949
Date of 1st FDA approval = 19490726
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Clostridium tetani
Corynebacterium diphtheriae
Mueller and Miller medium
aluminum phosphate
Diphtheria Toxoid
formaldehyde
Tetanus Toxoid
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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