Tetanus Immune Globulin (Human)
Status: approvals withdrawn
Organizations involved:
Grifols Biologicals Inc. – Former
Instituto Grifols, S.A. – Former
Probitas S.A. – Parent; Former
Alpha Therapeutic Corp. – Former
Green Cross Corp. – Former
Yoshitomi Pharmaceutical Industries, Ltd. – Former
Abbott Laboratories – R&D; Tech.; Former
Cross ref: See the entry (#784) above for Tetanus Immune Globulin Products.
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 (inactivated toxin from Clostridium tetani bacteria; see Tetanus Toxoid Vaccines entry, #543).
Nomenclature: Tetanus Immune Globulin/Grifols [BIO]; Tetanus Immune Globulin (Human) [FDA]
Companies.: The product was previously manufactured by Alpha Therapeutic Corp. (Los Angeles, CA), CBER/FDA est. lic. no. 0744, (originally independent, later a subsidiary of Green Cross Corp., a subsidiary of Yoshitomi Pharmaceutical Industries, Ltd.. later a subsidiary of Mitsubishi Chemical) Alpha was acquired by Probitas Pharma S.A. in July 2003 and merged into its Instituto Grifols subsidiary, after which approval of this product was revoked. This product was originally developed, manufactured and marketed by Abbott Labs.; and was among those acquired by Alpha Therapeutic when it purchased Abbott’s plasma processing facilities and products in the late 1970s.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19710430; first approval (PLA) granted to Abbott Labs.
Date = 19780815; license revoked and granted (reissued) to Alpha Therapeutic Corp. (new owner)
Date = 20030815; PLA revoked
Indications: product insert/labeling not available; for post-exposure prophylaxis and treatment of disease due to Clostridium tetani infection [unofficial]
Status: On August 15, 2003, FDA revoked the license for Tetanus Immune Globulin (Human), as requested by Grifols. It is no longer manufactured or marketed.
Companies involvement:
Full monograph
786 Tetanus Immune Globulin/Grifols
Nomenclature:
Tetanus Imm. Glob./Grifols [BIO]
Tetanus Immune Globulin (Human) [FDA]
FDA Class: Biologic PLA
Year of approval (FDA) = 1971
Date of 1st FDA approval = 19710430
(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
Plasma (Human)
Tetanus Toxoid Adsorbed
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
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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