Status: discontinued; no longer manufactured
Organizations involved:
Novo Nordisk Pharmaceuticals, Inc. – Manuf; USA mark.; Former inv.
Novo Nordisk A/S – Manuf. other; Tech.; Parent co.; Former inv.
Cross ref: See the Insulin Products entry above.
Description: Insulin, Beef is insulin derived from bovine (cow) pancreas tissue. Beef insulin is composed of 21-amino acid chain A linked via cysteine at residue 7 to cysteine at residue 7 of 22-amino acid chain A. It has a molecular weight of 5733.61 Daltons (about 5.7 kDa).
Bovine insulin is no longer marketed in the U.S. As with other types of insulin, various formulations had been marketed with different pharmacokinetic properties. Novo formerly marketed Insulin, Beef (regular uncomplexed); Insulin, Beef, Zinc Suspension (Lente), a zinc crystal suspension; Insulin, Beef, Extended Zinc Suspension (Ultralente), a zinc crystal suspension with even longer onset and duration; and Insulin, Beef, Isophane Suspension, a (Neutral Protamine Hagedorn or NPH suspension of insulin adsorbed to protamine crystals).
Nomenclature: Insulin, Beef/Novo [BIO]; Insulin, Beef [FDA]; Insulin, Beef, Zinc Suspension (Lente) [FDA]; Insulin, Beef, Isophane Suspension [FDA]; Insulin, Beef, Isophane Suspension (NPH Insulin) [FDA]; Insulin, Zinc Extended [FDA USAN]; Insulin, Isophane [USAN]; Insulin Zinc [CAS USAN BAN]; Compound Insulin Zinc Suspension [INN]; Insulin Zinc Injection [JAN]; Insulin, (ox) [CAS for regular]; 11070-73-8 [CAS RN for regular]; 8049-62-5 [CAS RN for Isophane]; bovine insulin [SY]
Companies: Insulin, Beef was manufactured by Novo Nordisk Pharmaceuticals Industries, Inc. (Clayton, NC), and/or at parent company facilities in Denmark. Its was marketed in the U.S. by Novo Nordisk Pharmaceuticals Industries, Inc. and internationally by Novo Nordisk.
FDA class: Drug NDA
Approvals: Date = original approval date unknown (See the History section of the Insulin Products entry)
Indications: for treatment of diabetes [unofficial]
Status: Beef insulin is still approved, but is no longer manufactured or marketed in the U.S. Lilly phased it out in 1998. Before the advent of recombinant insulins, decades ago, pork (not beef) insulin largely dominated the market.
Index Terms:
Companies involvement:
Full monograph
631 Insulin, Beef/Novo
Nomenclature:
Insulin, Beef/Novo [BIO]
Insulin, Beef [FDA]
Insulin, Beef, Zinc Suspension (Lente) [FDA]
Insulin, Beef, Isophane Suspension [FDA]
Insulin, Beef, Isophane Suspension (NPH Insulin) [FDA]
Insulin, Zinc Extended [FDA USAN]
Insulin, Isophane [USAN USP]
Insulin Zinc [CAS USAN BAN]
Compound Insulin Zinc Suspension [INN]
Insulin Zinc Injection [JAN]
Insulin, (ox) [CAS for regular]
11070-73-8 [CAS RN for regular]
8049-62-5 [CAS RN for Isophane]
bovine insulin [SY]
FDA Class: Drug NDA
biopharmaceutical products
bovine materials used<!-- bovinesource -->
hormones
insulin, recombinant human
bovine pancreas
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
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