Status: approved; not marketed, used as intermediate

Organizations involved:

Baxter Hyland Immuno – Manuf.

Baxter Healthcare Corp. – Parent

Cross ref: See the entry (#748) for Cytomegalovirus Immune Globulin Intravenous (Human) or CytoGam.

Description: CMV High Titer Fraction II+III Paste (For Further Manufacturing Use) is an intermediate concentrate of polyclonal cytomegalovirus (CMV) immune globulin fractionated and purified from pooled Plasma from persons with high titers of CMV antibodies. The product is used exclusively for further manufacture. This could include manufacture of Cytomegalovirus Immune Globulin Intravenous (Human) or CytoGam by Massachusetts Public Health Biologic Labs. and/or use for diagnostic products.

Nomenclature: CMV Immune Globulin conc. [BIO]; CMV High Titer Fraction II+III Paste (For Further Manufacturing Use) - Cytomegalovirus immune globulin fraction [FDA]; cytomegalovirus immune globulin concentrate [SY]

Companies.: The product is manufactured by Baxter Hyland Immuno (Glendale, CA), FDA CBER est. no. 0140. Uses for this intermediate are unknown.

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date = 19950331; first approval, PLA

Indications: unknown; not available

Status: This product is approved only as an intermediate for manufacture of other (unspecified) products.