Lederle
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use, Aluminum Phosphate Adsorbed - Td vaccine
Status: approvals withdrawn
Organizations involved:
Wyeth/Lederle Labs. – Manuf.; R&D; Tech.; Former
Wyeth – World mark.; Former
Cross ref: See the entries for DTP vaccine (Tri-Immunol) (#449) and DTaP vaccine (ACEL-IMUNE) (#435) for further information. See the entry for a component of this combination vaccine, Tetanus Toxoids Adsorbed (#421). See the entries for Tetanus Toxoid Vaccines (#543); and Diphtheria Toxoid Products (#418).
Description: This is a combination vaccine manufactured by mixing Tetanus Toxoids Adsorbed and Diphtheria Toxoids Adsorbed from Wyeth/Lederle Labs.
The vaccine was supplied in 10 dose 5.0 mL vials and Single Dose Lederject Disposable Syringes containing 0.5 mL. Each 0.5 mL dose contains 5 Lf units of tetanus toxoid and not more than 2 Lf units of diphtheria toxoid. The tetanus toxoid component induces at least 2 neutralizing units/mL of serum and the diphtheria toxoid component induces at least 0.5 neutralizing units/mL of serum in the guinea pig potency test. The vaccine is stored at 2-8˚C (refrigerated).
Nomenclature: Tetanus & Diphtheria Toxoids/Lederle [BIO]; Tetanus and Diphtheria Toxoids Adsorbed Purogenated for Adult Use [TR Purogenated is the reg. trademark]; Tetanus and Diphtheria Toxoids Adsorbed for Adult Use [FDA]; Tetanus and Diphtheria Toxoids Combined Aluminum Phosphate Adsorbed [FDA former]; Tetanus and Diphtheria Toxoids Combined Alum Precipitated [FDA former]; Td vaccine [SY]; NDC 0005-1875-31; NDC 0005-1875-47 [NDC]
Companies.: This vaccine was manufactured by Wyeth/Lederle Labs. (Pearl River, NY), CBER/FDA lic. no. 0017. The vaccine was marketed in the U.S. by Wyeth and, perhaps, internationally by Wyeth.
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = 19541114; according to Wyeth
Date = 19620406; fist approval; according to 1979 Office of Technology Assessment (OTA) vaccines approvals list
Date = 19700729; first approval; according to CBER/FDA database; However, an FDA letter on this date reports that the product license was withdrawn and a new product license was granted using the current FDA proper name.
Indications: product insert/labeling not available
Status: In Jan. 2001, Wyeth-Ayerst announced it was discontinuing manufacture of tetanus toxoid and all combination vaccines containing a tetanus toxoid component. This vaccine no longer appears on CBER/FDA approval lists, indicating its license was voluntarily withdrawn.
Companies involvement:
Full monograph
557 Tetanus & Diphtheria Toxoids/
Nomenclature:
Tetanus & Diphtheria Toxoids/Lederle [BIO]
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use [FDA]
Tetanus and Diphtheria Toxoids Combined Alum Precipitated (for Adult Use) [FDA former]
Td Vaccine [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1954
Date of 1st FDA approval = 19541217
(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)
FDA application withdrawn
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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