Status: approval withdrawn
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; Former
Cross ref: See the Tetanus Toxoid Products entry (#543), and the other Tetanus Toxoid entries. See also the combination vaccines, e.g., DTP and DTaP, from this manufacturer formerly incorporating this vaccine.
Description: Tetanus Toxoid is a vaccine containing formaldehyde-inactivated toxin (toxoid) obtained from fermentation of Clostridium tetani bacteria. This unadsorbed toxoid was not marketed (in recent years), and was likely used for further manufacture of Tetanus Toxoid Adsorbed and combination vaccines containing a tetanus toxoid component.
Nomenclature: Tetanus Toxoid/Wyeth [BIO]; tetanus toxoid [FDA]
Companies.: The product was formerly manufactured by Wyeth, CBER/FDA est. no. 0003. Wyeth has closed its Marietta, PA, manufacturing facility, and halted manufacture of this and other vaccines manufactured at this site.
FDA class: Biologic PLA
CBER class: Toxoids And Toxins For Immunization
Approvals: Date = unknown original approval date
Date = 19440519; first approval, according to CBER/FDA database and other FDA sources; However, FDA letters on this date report license withdrawal and reissuance to a new owner, Wyeth. In 1944, American Home Products, now Wyeth, acquired two vaccine companies, Gilli-land Labs. and Reichel Labs. It is not clear which company originally manufactured the vaccine.
Date = 19700729; first approval; according to other CBER/FDA sources; However, this is the date on which most tetanus toxoid product licenses were revoked and granted (reissued) under the current FDA proper name.
Status: In Jan. 2001, Wyeth-Ayerst discontinued manufacture of tetanus toxoid and all combination vaccines containing a tetanus toxoid component. This vaccine recently disappeared from CBER/FDA approval lists, indicating its license was voluntarily withdrawn.
Companies involvement:
Full monograph
548 Tetanus Toxoid/Wyeth
Nomenclature:
Tetanus Toxoid/Wyeth [BIO]
Tetanus Toxoid [FDA]
tetanus toxin, inactivated [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1944
Date of 1st FDA approval = 19440519
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, subunit
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Clostridium tetani
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)
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
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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