Status: U.S. approval withdrawn; was a manufacturing intermediate

Organizations involved:

Grifols Biologicals Inc. – R&D; Tech.

Probitas S.A.– Parent

Alpha Therapeutic Corp. – R&D; Tech.; Former.

Green Cross Corp. – Former

Yoshitomi Pharmaceutical Industries, Ltd. – Former

Mitsubishi Chemical Corp. – Former

Abbott Laboratories – R&D; Tech.; Former

Cross ref: See the entries for Hepatitis B Immune Globulin Products (#751) and Immune Globulin Products (#638). See the Hepatitis B Vaccine Products entry (#468) for background about hepatitis B virus and chronic hepatitis B.

Description: Hepatitis B Immune Globulin (Human) is a preparation of purified virus-inactivated immune globulin containing high titers of hepatitis B virus antibodies obtained from fractionated pooled plasma from donors with high titers of hepatitis B virus antibodies (having received vaccination with one of the two approved hepatitis B virus vaccines).

The product’s U.S. approval allowed manufacture and sales to other companies for further manufacture of hepatitis B virus immune globulin.

Nomenclature: Hepatitis B Immune Globulin/Grifols [BIO]; Hepatitis B Immune Globulin (Human) [FDA]

Companies.: The product was approved for manufacture by Alpha Therapeutic Corp. (originally independent, later a subsidiary of Green Cross Corp., a subsidiary of Yoshitomi Pharmaceutical Industries, Ltd., later acquired by Mitsubishi Chem-ical), CBER/FDA lic. no. 0744, now Grifols Biological Inc. Alpha was acquired by Probitas Pharma S.A. in July 2003 and merged into its Instituto Grifols subsidiary (Grifols Biological Inc. in the U.S.). The product was marketed in the U.S. by Alpha Therapeutic Corp., and internationally by Alpha affiliates, including Green Cross and Yoshitomi.

The product was originally developed and manufactured 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 = 19770615; first approval, PLA, granted to Abbott Labs.

Date = 19780815; first approval, according to the CBER/FDA database and other FDA sources; However, an FDA letter on this date reports that licenses were withdrawn and reissued to Alpha Therapeutic Corp., the new owner.

Status: The FDA product license was voluntarily revoked in recent years, and the product is presumably no longer manufactured.