Status: approval withdrawn

Organizations involved:

Baxter Hyland Immuno – Former

Immuno-U.S. – Former

Immuno AG - Parent; Former

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

Description: Antihemophilic Factor (Human) was a formulation of Factor VIII protein fractionated and purified from pooled human blood plasma by Immuno-U.S. Subsequent to the acquisition of Immuno AG by Baxter Healthcare, the product is no longer approved or manufactured (replaced in Baxter’s product line by recombinant Factor VIII).

Nomenclature: Factor VIII/Baxter [BIO]; Antihemophilic Factor (Human) [FDA]; Antihemophilic Factor [USAN]; Antihemophilic Factor, Human [USAN former]; Factor VIII [SY]

Companies.: The product was formerly manufactured and marketed by Immuno-U.S., Inc. (Rochester, MI), FDA CBER est. no. 0850, a subsidiary of Immuno AG (Vienna, Austria), now part of Baxter Hyland Immuno. Immuno AG was acquired by Baxter in 1997.

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date = 19810204; first approval; Indication = for treatment of hemophilia type A

Date = 19830221; addition of heat viral inactivation

Date = 20000119; license revoked

Status: The PLA/BLA was voluntarily revoked in 2000.