Antihemophilic Factor (Human); Factor VIII
Status: approval revoked; formerly sold for further manufacture only
Organizations involved:
Talecris Biotherapeutics Inc. – Manuf; R&D; Tech.; USA mark.; Former
Instituto Grifols, S.A. – Parent
NPS Pharmaceuticals Inc – Parent; Former
Precision Pharma Services, Inc.. – Former
V.I Technologies, Inc. – Former
Melville Biologics, Inc. – Former
Cross ref: See the Factor VIII Products entry (#715).
Description: Antihemophilic Factor (Human) from Precision Pharma Services, Inc. (formerly V.I. Technologies, Inc.) is a Factor VIII protein preparation fractionated and purified from pooled human blood Plasma.
This product was exclusively sold to Bayer Corp. (later Talecris Biotherapeutics, later Instituo Grifols) for further manufacturing and marketing.
Nomenclature: Factor VIII/Talecris [BIO]; Antihemophilic Factor [USAN]; Antihemophilic Factor, Human [former USAN]; Antihemophilic Factor USP [USP]; Blood-coagulation factor VIII, complex [CAS]; 9001-27-8 [CAS RN]; AHF [SY]; Factor VIII [SY]
Companies.: The product was manufactured by Precision Pharma Services, Inc., FDA CBER est. no. 0386, formerly V.I Technologies, Inc. (VITEX) and before that, Melville Biologics, Inc. It was sold to Bayer Corp. (Berkeley, CA), FDA CBER est. no. 0008, for further manufacturing only. Precision Medical is a separate company that was spun-off from V.I. Technologies (now merged into Panacos Pharmaceuticals) to continue its plasma processing operations, while V.I. Technologies (merged with Panacos in mid-2004) concentrates on developing viral inactivation technologies.
In April 2005, Talecris Biotherapeutics Inc., a subsidiary of NPS Pharmaceuticals Inc., acquired Precision Pharma Services, Inc. (along with the blood/plasma products business of Bayer).
Talecris has exclusive U.S. marketing rights. In Feb. 2011, Grifols S.A./Instituto Grifols acquired Talecris Biotherapeutics.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19750618; first approval, PLA; Indication = for treatment of hemophilia type A
Date = 19990630; supplemental approval; Indication = addition of claims regarding final product testing for hepatitis A virus (HAV) and screening out of plasma from hepatitis A virus-infected donors using highly sensitive PCR or NAT.
Status: The product license was voluntarily revoked in recent years.
Companies involvement:
Full monograph
720 Factor VIII/Talecris
Nomenclature:
Factor VIII/Talecris [BIO]
Antihemophilic Factor [USAN]
Antihemophilic Factor, Human [former USAN]
Antihemophilic Factor USP [USP]
Blood-coagulation factor VIII, complex [CAS]
9001-27-8 [CAS RN]
AHF [SY]
Factor VIII [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1975
Date of 1st FDA approval = 19750618
(in format YYYYMMDD)
Index Terms:
antihemophilic factors
biopharmaceutical products
blood products
human materials used<!-- humansource -->
Plasma (Human)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
Copyright© 2020, Biotechnology Information Institute