Normal Horse Serum – equine blood serum
Status – approvals withdrawn
Organizations involved:
Wyeth Pharmaceuticals. – Manuf.; Former
Cross ref: See the Horse Serum Products entry, and the entry above for the approved Horse Serum product.
Description: Normal Horse Serum is serum derived from horses (equine). Normal Horse Serum is packaged in kits for detection of hypersensitivity (allergy) to equine antivenin products (equine immune globulins for neutralization of snake venoms/toxins, including those from Wyeth). It is used to test for hypersensitivity prior to administration of antivenin.
Nomenclature: Horse Serum/Wyeth [BIO]; Normal Horse Serum [FDA]; equine blood serum [SY]
Companies.: Normal Horse Serum was approved for manufacture by Wyeth (Marietta, PA), CBER/FDA est. lic. no. 0003. Wyeth has closed its Marietta, PA, facility, no longer manufacture the product, and similarly has discontinued its antivenin products.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19440519; first approval
Status: The product approval was withdrawn in 2004/5, with the product no longer appearing on CBER/FDA lists of approved products. This product was only marketed as part of antivenin hypersensitivity detection kits.
Companies involvement:
Full monograph
905 Horse Serum/Wyeth
Nomenclature:
Horse Serum/Wyeth [BIO]
Normal Horse Serum [FDA]
equine blood serum [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1944
Date of 1st FDA approval = 19440519
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
blood products
plasma (equine)
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)
FDA application withdrawn
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EU011 Approved Formerly in EU/withdrawn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US011 Approved Formerly in US/withdrawn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
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