Status: withdrawn from the U.S. market

Organizations involved:

BioPort Corp. – Manuf.; R&D; Tech.

Michigan Biologics Products Institute – Former

Cross ref.: See the Diphtheria Toxoid Products entry above.

Description: Diphtheria Toxoid Adsorbed from BioPort is an aqueous formulation of purified, aluminum hydroxide-adsorbed, formaldehyde-inactivated Corynebacterium diph-theriae toxin (toxoid) obtained from culture of C. diphtheriae (Park-William strain no. 8) bacterium. The toxin is separated from culture media using the Pillemer alcohol-fractionation method, and further purified using metaphosphoric acid, followed by inactivation with formaldehyde, and adsorption onto aluminum hydroxide adjuvant. The product contains at >2 antitoxin units/mL as determined by guinea pig potency and detoxification assays.

Nomenclature: Diphtheria Toxoid/BioPort [BIO]; Diphtheria Toxoid Adsorbed [FDA USAN]; Diphtheria Toxoid Aluminum Phosphate Adsorbed [FDA former]

Companies.: This vaccine was formerly manufactured by the Michigan Department of Public Health (Michigan Biologics Products Institute), now BioPort Corp., CBER/FDA est. 1260.

SmithKline Beecham Corp. (now GlaxoSmithKline Inc.) previously marketed a Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) product in the U.S., using components manufactured by the Michigan Biologics Products Institute (now BioPort Corp.).

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19560818; first approval granted to Michigan Department of Public Health, according to 1979 Office of Technology Assessment (OTA) vaccines approval list

Date = 19700827; first approval, according to the CBER/FDA database. However, an FDA letter to the company on this date states that approval was revoked and granted (reissued) using a new (the current) FDA proper name

Date = 19981112; approval revoked and granted (reissued) to new owner, BioPort Corp.

Date = 20001020; license voluntarily revoked

Indications: product insert/labeling not available

Status: The product is no longer approved, manufactured, or marketed. License revocation was announced in the Federal Register, May 29, 2001, 66 (103), p. 29148-9.