Tetanus Immune Globulin (Human) - TIG
Status: FDA approval withdrawn
Organizations involved:
Massachusetts Biological Labs. – Manuf.; R&D; Tech.; Former
Massachusetts, State of – Parent; Former
Cross ref: See the Tetanus Immune Globulin Products entry (#784).
Description: Tetanus Immune Globulin (Human) is an aqueous formulation of immune globulin containing high titers of antibodies to tetanus toxin obtained from pooled fractionated Plasma from persons immunized with Tetanus Toxoid (see the Tetanus Toxoid Vaccines entry, #543).
Nomenclature: Tetanus Immune Globulin/Mass. [BIO]; Tetanus Immune Globulin [USAN]; Tetanus Immune Human Globulin [USP]; Tetanus Immune Globulin (Human) [SY]; TIG [SY]
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19680506; first approval, PLA
Indications: product insert/labeling not available; for post-exposure prophylaxis of disease due to Clostridium tetani infection [unofficial]
Status: The product approval was revoked in 2004/5 (no longer appearing on CBER/FDA approved product list).
Companies involvement:
Full monograph
787 Tetanus Immune Globulin/Mass.
Nomenclature:
Tetanus Immune Globulin/Mass. [BIO]
Tetanus Immune Globulin [USAN]
Tetanus Immune Human Globulin [USP]
Tetanus Immune Globulin (Human) [SY]
TIG [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1968
Date of 1st FDA approval = 19680506
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
Clostridium tetani
ethanol
Plasma (Human)
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US011 Approved Formerly in US/withdrawn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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