Status: approvals withdrawn; not marketed

Organizations involved:

Merck & Co., Inc. – Manuf.; R&D; Tech.; World mark.; Former

Cross ref.: See the Horse Serum Products entry.

Description: Normal Horse Serum is serum derived from the blood of horses (equine).

Nomenclature: Horse Serum/Merck [BIO]; Normal Horse Serum [FDA]; equine blood serum [SY]

Companies.: Normal Horse Serum is approved for manufacture by Merck & Co., Inc., CBER/FDA est. no. 0002.

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date = 19590102; first approval, PLA

Status: The Merck medical information department reports that this product is not on their master list of company products, which they assert indicates it was never marketed in the U.S. (although the product’s multi-decade U.S. approval suggests otherwise). The product recently disappeared from CBER/FDA approval lists, indicating that approval was voluntarily withdrawn. Presumably, withdrawals in other countries have also been withdrawn.

Like the Wyeth-Ayerst horse serum product, this product was probably used in kits for detection of hypersensitivity (allergy) to horse proteins, e.g., for detection of hypersensitivity prior to using an equine antivenin or immune globulin product.

The approval status in European and other countries is uncertain.