Status: approvals withdrawn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Pharma S.A. in July 2003 and merged into its Instituto Grifols subsidiary, after which approval of this product was revoked.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.