Status: approval withdrawn

Organizations involved:

BioPort Corp. – Manuf.; Tech.; World mark; Former

Emergent Biosolutions Inc. – Parent

Michigan Biologics Products Institute – Former

Cross ref: See also Factor VIII Products (entry #715).

Description: Antihemophilic Factor (Human) or Factor VIII from Bioport is Factor VIII (or Factor VIII:C) fractionated and purified from pooled human blood plasma.

Nomenclature: Factor VIII/BioPort [BIO]; Antihemophilic Factor (Human) [FDA]; Antihemophilic Factor [USAN]; Antihemophilic Factor, Human [former USAN]; Antihemophilic Factor USP [USP]; Blood-coagulation factor VIII, complex [CAS]; 9001-27-8 [CAS RN]; Factor VIII [SY]; Antihemophilic Factor VIII [SY]; AHF [SY]

Companies.: The license for manufacture was until recent years held by BioPort Corp. (formerly Michigan Biologics Products Institute; before that, Michigan Department of Public Health), CBER/FDA est. no. 0099, a subsidiary of Emergent Biosolutions Inc.

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date = 19831229; first approval, PLA, granted to the Michigan Department of Public Health

Date = 19981112; PLA/ELA licenses revoked and granted (reissued) to new owner, BioPort Corp.

Indications: hemophilia type A [unofficial]

Status: The product license was voluntarily revoked in recent years. Since it was not marketd, the product was likely resold to other licensed establishments for further manufacture of Factor VIII products.